Clinical Studies
Brain Health
Ashwagandha promotes memory and cognition in two ways: by impacting cognitive function directly, and by lowering stress and improving sleep and mental alertness. KSM-66 Ashwagandha root extract has been clinically proven to improve executive function, immediate memory, information processing speed, and concentration.
Study 1
Title: A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly reduced stress and anxiety assessment scores and serum cortisol levels, compared to a placebo. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in enhancing stress resistance and improving quality of life.
Chandrasekhar et al., 2012; Indian journal of psychological medicine, 34(3), 255–262.Study 2
Title: Body Weight Management in Adults Under Chronic Stress Through Treatment with Ashwagandha Root Extract: A Double-Blind, Randomized, Placebo-Controlled Trial.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly reduced stress and food cravings scores and serum cortisol levels, compared to the placebo. Ashwagandha root extract also significantly increased happiness scores. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in reducing stress resistance and stress-related food cravings.
Choudhary D et al., 2017; Journal of evidence-based complementary & alternative medicine, 22(1), 96–106Study 3
Title: Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study.
Conclusion: The study demonstrated that Ashwagandha root extract (250mg/day and 600mg/day) significantly reduced stress, anxiety, and serum cortisol levels, compared to the placebo. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in reducing stress and anxiety (600mg/day being more efficacious, compared to 250mg/day).
Salve, J., et al (2019).Cureus, 11(12), e6466.Study 4
Title: Efficacy and Safety of Ashwagandha Root Extract in the Management of Frailty in Older Adults: A Prospective, Randomized, Placebo-Controlled Study
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly reduced frailty score, perceived stress score, serum cortisol level, and improved quality of life in elderly participants. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in improving stress resistance and overall well-being in the elderly.
Efficacy and Safety of Ashwagandha Root Extract in the Management of Frailty in Older Adults: A Prospective, Randomized, Placebo-Controlled Study (Under Peer Review).Study 5
Title: Adaptogenic and Immunomodulatory Activity of Ashwagandha Root Extract: An Experimental Study in an Equine Model.
Conclusion: The study demonstrated that Ashwagandha root extract supplementation (2.5 gm/animal, 5 gm/animal, and 10 gm/animal per day) in horses exhibited a significant reduction in cortisol and epinephrine levels and an increase in hemoglobin, total erythrocyte count, total leucocyte counts, and lymphocyte percentage.The findings suggest that Ashwagandha root extract is safe and effective in reducing stress in horses.
Priyanka G et al., 2020, Frontiers in Veterinary Sciences 7:541112.Study 6
Title: Efficacy and Safety of Standardized Ashwagandha (Withania somnifera) Root Extract on Reducing Stress and Anxiety in Domestic Dogs: A Randomized Controlled Trial.
Conclusion: The study demonstrated that Ashwagandha root extract supplementation (15 mg/kg body weight) in dogs significantly reduced cortisol levels, fear and anxiety, and CBPI pain severity and pain interference domain scores compared to placebo. The supplementation was well-tolerated with no adverse events reported. The findings suggest that Ashwagandha root extract is safe and effective in reducing stress, fear, and anxiety in dogs.
Kaur J, et al., (2022) Journal of Veterinary Behavior, 51, 8-15.Study 7
Title: Adaptogenic Ashwagandha root extract modulates inflammatory markers in feline stress management: a double-blind placebo-controlled clinical trial.
Conclusion: The study demonstrated that supplementation with Ashwagandha root extract (15 mg/kg body weight) in cats significantly reduced cortisol levels and increased hematological parameters. No detrimental changes were observed in liver and kidney function parameters. The supplementation was well-tolerated, with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in reducing stress and inflammation in cats.
Devarasetti, A. K., et al., (2024). Journal of Applied Animal Research, 52(1).Study 1
Title: Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Insomnia and Anxiety: A Double-blind, Randomized, Placebo-controlled Study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved sleep actigraphy parameters such as sleep onset latency, total sleep time, and sleep efficiency, compared to the placebo. Ashwagandha root extract also significantly reduced anxiety. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in reducing anxiety and improving sleep in adults.
Langade, D., et al (2019). Cureus, 11(9), e5797Study 2
Title: Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly reduced anxiety and improved sleep actigraphy parameters such as sleep onset latency, total sleep time, sleep efficiency, and mental alertness on rising compared to the placebo in both healthy participants and insomnia patients. The supplementation was well-tolerated, and no adverse events were reported. These findings suggest that Ashwagandha root extract is safe and effective in reducing anxiety and improving sleep for both healthy participants and insomnia patients.
Langade, D., et al., (2020). Journal of Ethnopharmacology: 264:113276.Study 3
Title: Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study.
Conclusion: The study demonstrated that Ashwagandha root extract (250mg/day and 600mg/day) significantly improved the quality of sleep. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving sleep and reducing anxiety (600mg/day being more efficacious, compared to 250 mg/day).
Salve, J., et al (2019).Cureus, 11(12), e6466.Study 4
Title: Efficacy and Tolerability of Ashwagandha Root Extract in the Elderly for Improvement of General Well-being and Sleep: A Prospective, Randomized, Double-blind, Placebo-controlled Study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved sleep quality, quality of life, and mental alertness on rising in elderly participants. The supplementation was well-tolerated, and no adverse events were reported. These findings suggest that Ashwagandha root extract is safe and effective in improving sleep and general well-being in the elderly.
Kelgane, S. B., et al., (2020). Cureus, 12(2), e7083.Study 5
Title: Efficacy and Safety of Ashwagandha Root Extract in the Management of Frailty in Older Adults: A Prospective, Randomized, Placebo-Controlled Study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved sleep quality, quality of life, and cognitive function in elderly participants. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in improving sleep, cognitive function, and overall well-being in the elderly.
Efficacy and Safety of Ashwagandha Root Extract in the Management of Frailty in Older Adults: A Prospective, Randomized, Placebo-Controlled Study (Under Peer Review).Study 6
Title: A clinical assessment of the pharmacological effects of Ashwagandha root extract on parent-reported functions of cognition, behavior, sleep, fatigue, and executive function in children aged 6-12 years.
Conclusion: The study demonstrated that Ashwagandha root extract (300mg/day) significantly improved Sleep Disturbance Scale for Children scores, indicating better sleep-related behavior in children. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in enhancing children's sleep quality.
A clinical assessment of the pharmacological effects of Ashwagandha root extract on parent-reported functions of cognition, behavior, sleep, fatigue, and executive function in children aged 6-12 years (Under Peer Review).Study 7
Title: Efficacy of Ashwagandha Root Extract in Treatment of Hyperactivity Disorder (ADHD) in Children Aged 5-12 Years.
Conclusion: The study demonstrated that Ashwagandha root extract (300mg/day) significantly reduced Hyperactivity-Impulsivity domain scores, sleep disturbance, and anxiety in children. KSM-66 Ashwagandha did not show any significant effect on the hepatic and renal parameters. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in improving sleep quality and symptoms of ADHD in children.
Efficacy of Ashwagandha Root Extract in Treatment of Hyperactivity Disorder (ADHD) in Children Aged 5-12 Years (Under Peer Review).Study 1
Title: Efficacy and Safety of Ashwagandha (Withania somnifera (L.) Dunal) Root Extract in Improving Memory and Cognitive Functions.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved immediate memory, general memory, executive function, and attention and information processing speed, compared to placebo in adults. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in enhancing memory, executive function, and attention in adults.
Choudhary, D., et al., (2017). Journal of dietary supplements, 14(6), 599–612.Study 2
Title: Ashwagandha Root Extract on Cognition, Energy, and Mood in Adults with Cognitive and Energy Problems: A Prospective, Placebo-Controlled Study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved episodic memory, working memory, executive function, and the accuracy of attention, mental fatigue, mood, and vigor, compared to a placebo in adults. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in improving memory, cognition, mood, and fatigue in adults.
Kale, S., et al., (2024), Journal of psychoactive drugs, 1–13.Study 3
Title: A clinical assessment of the pharmacological effects of Ashwagandha root extract on parent-reported functions of cognition, behavior, sleep, fatigue, and executive function in children aged 6-12 years.
Conclusion: The study demonstrated that Ashwagandha root extract (300mg/day) significantly improved episodic memory, working memory, attention, executive function, and information processing speed, compared to the placebo group. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in enhancing children's memory, cognition, and executive function.
A clinical assessment of the pharmacological effects of Ashwagandha root extract on parent-reported functions of cognition, behavior, sleep, fatigue, and executive function in children aged 6-12 years (Under Peer Review).Study 4
Title: Efficacy of Ashwagandha Root Extract in Treatment of Hyperactivity Disorder (ADHD) in Children Aged 5-12 Years.
Conclusion: The study demonstrated that Ashwagandha root extract (300mg/day) significantly reduced Inattention and Hyperactivity-Impulsivity domain scores, and anxiety in children. KSM-66 Ashwagandha did not show any significant effect on the hepatic and renal parameters. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in improving attention, and symptoms of ADHD in children.
Efficacy of Ashwagandha Root Extract in Treatment of Hyperactivity Disorder (ADHD) in Children Aged 5-12 Years (Under Peer Review)Sports Health
Ashwagandha enhances athletic performance by boosting muscle growth, strength, and endurance. It improves cardiovascular endurance by increasing VO2 max, which is crucial for athletes in stamina-demanding sports. KSM-66 Ashwagandha root extract is clinically proven to enhance physical performance by supporting muscle recovery and reducing the impact of stress on the body during intense physical activity.
Study 1 - Cardiorespiratory endurance (AYU)
Title: Efficacy of Ashwagandha (Withania somnifera [L.] Dunal) in improving cardiorespiratory endurance in healthy athletic adults.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved maximal oxygen capacity and quality of life compared to a placebo in adults. The supplementation was well-tolerated, and no adverse events were reported. These findings suggest that Ashwagandha root extract is safe and effective in improving cardiorespiratory endurance and overall quality of life in adults.
Choudhary, B., et al. (2015). Ayu, 36(1), 63–68.Study 2 - Cardiorespiratory endurance and Recovery
Title: A double-blind, randomized, placebo-controlled trial on the effect of Ashwagandha (Withania somnifera dunal.) root extract in improving cardiorespiratory endurance and recovery in healthy athletic adults.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved maximal oxygen capacity and total quality recovery, compared to a placebo in adults. The supplementation was well-tolerated, and no adverse events were reported. These findings suggest that Ashwagandha root extract is safe and effective in improving cardiorespiratory endurance and overall quality of recovery in adults.
Tiwari, S., et al., (2021). Journal of ethnopharmacology, 272, 113929.Study 3 - Muscle Strength and Endurance (F1000)
Title: Effects of Ashwagandha (Withania somnifera) standardized root extract on physical endurance and VO2max in healthy adults performing resistance training: An eight-week, prospective, randomized, double-blind, placebo-controlled study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved maximal oxygen capacity and strength in both men and women. The supplementation was well-tolerated, and no adverse events were reported. These findings suggest that Ashwagandha root extract is safe and effective in improving muscle strength and endurance in healthy adults.
Verma N, et al., (2023), F1000Research 2023, 12:335.Study 1 - Muscle strength, recovery and testosterone
Title: Examining the effect of Withania somnifera supplementation on muscle strength and recovery: a randomized controlled trial.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved muscle strength, muscle size and serum testosterone levels. There was a reduction in serum creatine kinase levels indicating faster recovery. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving muscle strength and testosterone levels, and recovery in adults.
Wankhede, S., et al., (2015).Journal of the International Society of Sports Nutrition, 12, 43.Study 2 - Muscle Strength and Endurance (F1000)
Title: Effects of Ashwagandha (Withania somnifera) standardized root extract on physical endurance and VO2max in healthy adults performing resistance training: An eight-week, prospective, randomized, double-blind, placebo-controlled study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved muscle strength, muscle size for arm, thigh and chest and cardiorespiratory endurance in both men and women. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving muscle strength and endurance in healthy adults.
Verma N, et al., (2023), F1000Research 2023, 12:335.Study 3 - Muscle Recovery and Testosterone
Title: Effect of Ashwagandha Root Extract on Serum Testosterone and Muscle Recovery in Strength Training.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly reduced the serum creatinine phosphokinase levels indicating faster recovery in both men and women. In addition, it significantly improved free testosterone and total testosterone levels in men. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in faster recovery in both men and women.
Verma N, et al., (2023), IJMPR, 4(5):371-381.Study 1 - Muscle strength and recovery
Title: Examining the effect of Withania somnifera supplementation on muscle strength and recovery: a randomized controlled trial.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved serum testosterone levels. In addition there was a significant increase in muscle strength and muscle while a significant reduction in serum creatine kinase levels indicating faster recovery. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving testosterone levels, muscle strength and recovery in adults.
Wankhede, S., et al., (2015).Journal of the International Society of Sports Nutrition, 12, 43.Study 2 - Muscle Recovery and Testosterone
Title: Effect of Ashwagandha Root Extract on Serum Testosterone and Muscle Recovery in Strength Training.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved free testosterone and total testosterone levels in men. There was a reduction in serum creatinine phosphokinase levels indicating faster recovery. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving testosterone levels and recovery in men.
Verma N, et al., (2023), IJMPR, 4(5):371-381.Sexual Function
Ashwagandha enhances sexual function in both men and women by addressing stress and potentially boosting testosterone levels in men and regulating hormone levels in women. KSM-66 Ashwagandha root extract is clinically proven to enhance sexual performance by increasing libido, sexual satisfaction, orgasms etc in both Men and Women.
Study 1 - Male Fertility and Testosterone
Title: Clinical Evaluation of the Spermatogenic Activity of the Root Extract of Ashwagandha (Withania somnifera) in Oligospermic Males: A Pilot Study.
Conclusion: The study demonstrated that Ashwagandha root extract (mg/day) significantly improved sperm concentration, semen volume, sperm motility, and serum testosterone levels. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving male fertility and testosterone levels.
Ambiye, V. R., et al., (2013). Evidence-based complementary and alternative medicine : eCAM, 2013, 571420.Study 2 - Sexual Wellness in Men
Title: Effect of standardized root extract of ashwagandha (Withania somnifera) on well-being and sexual performance in adult males: A randomized controlled trial.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved sexual functions, arousal, orgasm, and sexual drive. There was also a significant increase in physical functioning, energy/fatigue, emotional well-being, social functioning, pain and general well-being. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving sexual wellness in men.
Chauhan, S., et al., (2022). Health science reports, 5(4), e741.Study 3 - Male Fertility, Sexual Wellness and Testosterone in Men
Title: Efficacy and Safety of Eight-Week Therapy with Ashwagandha Root Extract in Improvement of Sexual Health in Healthy Men: Findings of a Prospective, Randomized, Double-Blind, Placebo-Controlled Study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved serum testosterone and dihydrotestosterone levels. There was also a significant improvement in semen volume, sperm count and sperm motility. In addition there was a significant increase in the level of sexual desire scores, number of satisfying sexual events, International Index of Erectile Function scores and improvement in overall quality of life. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving sexual wellness in men.
Efficacy and Safety of Eight-Week Therapy with Ashwagandha Root Extract in Improvement of Sexual Health in Healthy Men: Findings of a Prospective, Randomized, Double-Blind, Placebo-Controlled Study (Accepted for Publication).Study 4 - Sexual Wellness and Testosterone in Men
Title: Ashwagandha Root Extract Improves Sexual Health in Healthy Men: Findings of a Prospective, Randomized, Double-Blind, Placebo-Controlled Study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved total and free testosterone, sperm concentration, semen volume, sperm volume, level of sexual desire. There was also a significant increase in erectile function and quality of life. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving sexual wellness and testosterone in men.
Ashwagandha Root Extract Improves Sexual Health in Healthy Men: Findings of a Prospective, Randomized, Double-Blind, Placebo-Controlled Study (Under Peer Review).Study 5 - Sexual Wellness in Men (USA)
Title: Role of Ashwagandha Extract in Improving Sexual Health in Healthy Men: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved serum testosterone levels, level of sexual desire and Number of Satisfying Sexual Event scores. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving sexual wellness and testosterone in men.
Role of Ashwagandha Extract in Improving Sexual Health in Healthy Men: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study (Under Peer review).Study 1 - Sexual Health in Women
Title: Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Improving Sexual Function in Women: A Pilot Study.
Conclusion: The study showed that arousal, desire, orgasm, lubrication, and satisfaction domains as well as overall female sexual function index scores significantly improved with ashwagandha root extract (600 mg/day). A significant decrease in female sexual distress scale scores and an increase in the number of successful sexual encounters are also observed. The supplementation was well tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving sexual wellness in women.
Dongre, S. et al., 2015. BioMed Research International, 2015, 284154.Study 2 - Sexual Wellness and General Well-being in Women
Title: Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract for Improvement of Sexual Health in Healthy Women: A Prospective, Randomized, Placebo-Controlled Study.
Conclusion: The study demonstrated a significant improvement in arousal, desire, orgasm, lubrication, and satisfaction domains, as well as overall female sexual function index scores with ashwagandha root extract (600 mg/day). A significant decrease in female sexual distress scale scores and an increase in the number of successful sexual encounters and overall quality of life are also observed. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in improving sexual wellness in women.
Ajgaonkar A, et al., (2022) Cureus 14(10): e30787.Study 3 - Sexual Well-being in Women
Title: Efficacy and safety of ashwagandha root extract on sexual health in healthy women: findings of a prospective, randomized, double-blind, placebo-controlled study.
Conclusion: The study demonstrated a significant improvement in overall female sexual function index scores as well as arousal, desire, orgasm, lubrication, and satisfaction domains with ashwagandha root extract (600 mg/day). A significant improvement in the number of successful encounters and the level of sexual desire is observed. A significant reduction in the female sexual distress scale and perceived stress scores are also observed. The supplementation also resulted in an increase in estrogen levels and a reduction in follicle-stimulating hormone levels.
Mutha A, et al., (2025) Cogent Psychology, 12:1, 2459467Study 4 - Sexual Wellness in Women
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Effects of KSM-66 Ashwagandha® capsule (300 mg) on Sexual Health in Healthy Women.
Conclusion: The study demonstrated a significant improvement in overall female sexual function index scores as well as arousal, desire, orgasm, lubrication, and satisfaction domains with ashwagandha root extract (600 mg/day). A significant improvement in the number of intercourses, satisfying sexual activity and the level of sexual desire is observed. A significant reduction in the female sexual distress scale and perceived stress scores are also observed. The supplementation also resulted in an increase in estrogen levels and a reduction in progesterone hormone levels.
A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Effects of KSM-66 Ashwagandha® capsule (300 mg) on Sexual Health in Healthy Women (Accepted for Publication).Study 5 - Sexual Wellness in Women
Title: Effects of Ashwagandha Extract (Capsule KSM-66 300 mg) on Sexual Health in Healthy Women: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study.
Conclusion: The study demonstrated a significant improvement in overall female sexual function index scores as well as arousal, desire, orgasm, lubrication, and satisfaction domains with ashwagandha root extract (600 mg/day). A significant improvement in the number of intercourses, number of orgasms, and the level of sexual desire is observed. A significant reduction in the female sexual distress scale and perceived stress scores are also observed. The supplementation also resulted in an increase in estrogen levels.
Effects of Ashwagandha Extract (Capsule KSM-66 300 mg) on Sexual Health in Healthy Women: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study (Under Peer Review)Hormonal Health
Ashwagandha plays a crucial role in hormonal health by supporting the endocrine system. Its adaptogenic properties help in regulating hormone production, which can mitigate symptoms of hormone imbalances such as adrenal fatigue, stress, and thyroid issues. KSM-66 Ashwagandha root extract is clinically proven to support hormonal health by modulating stress hormones and supporting endocrine function.
Study 1 - Thyroid Health
Title: Efficacy and Safety of Ashwagandha Root Extract in Subclinical Hypothyroid Patients: A Double-Blind, Randomized Placebo-Controlled Trial.
Conclusion: The study showed a significant reduction in serum Thyroid Stimulating Hormone concentration and significant increase in serum Free Triiodothyronine and Free Thyroxine concentrations with Ashwagandha root extract supplementation (600 mg/day).
Sharma, A. K.,et al., (2018). Journal of alternative and complementary medicine (New York, N.Y.), 24(3), 243–248.Study 2 - Thyroid Safety
Title: Safety of Ashwagandha Root Extract: A Randomized, Placebo-Controlled, study in Healthy Volunteers.
Conclusion: The study showed that there was no statistically significant change or abnormality in thyroid profile with Ashwagandha root extract supplementation (600 mg/day).
Verma, N., et al., (2020). Complementary therapies in medicine, 57, 102642.Study 1 - Climacteric Symptoms in Perimenopausal Women
Title: Effect of an ashwagandha (Withania Somnifera) root extract on climacteric symptoms in women during perimenopause: A randomized, double-blind, placebo-controlled study.
Conclusion: The study demonstrated a significant reduction in the climacteric symptoms in women during perimenopause with Ashwagandha root extract (600mg/day). A significant reduction in Menopause rating scale, and Hot flashes was observed when compared to the placebo (p < 0.001). There was a significant increase in Estradiol levels and reduction in Follicle stimulating hormone, and luteinizing hormone levels.
Gopal, S., et al., (2021). The journal of obstetrics and gynaecology research, 47(12), 4414–4425.Study 2 - Menopausal Symptoms in Women
Title: Efficacy And Safety of KSM66 Ashwagandha (Withania somnifera) Standardized Root Extract for Treatment of Menopausal symptoms in women: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study.
Conclusion: The study demonstrated a significant reduction in the menopausal symptoms in women with Ashwagandha root extract (600mg/day). A significant reduction in Menopause rating scale, and number of hot flashes was observed when compared to the placebo (p< 0.001) and a significant increase in estradiol levels.
Efficacy And Safety of KSM66 Ashwagandha (Withania somnifera) Standardized Root Extract for Treatment of Menopausal symptoms in women: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study (Under Peer review).Study 1 - Male Fertility and Testosterone
Title: Clinical Evaluation of the Spermatogenic Activity of the Root Extract of Ashwagandha (Withania somnifera) in Oligospermic Males: A Pilot Study.
Conclusion: The study demonstrated that Ashwagandha root extract (mg/day) significantly improved sperm concentration, semen volume, sperm motility, and serum testosterone levels. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving male fertility and testosterone levels.
Chauhan, S., et al., (2022). Health science reports, 5(4), e741.Study 2 - Sexual Wellness in Men
Title: Effect of standardized root extract of ashwagandha (Withania somnifera) on well-being and sexual performance in adult males: A randomized controlled trial.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved sexual functions, arousal, orgasm, and sexual drive.There was also a significant increase in physical functioning, energy/fatigue, emotional well-being, social functioning, pain and general well-being. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving sexual wellness in men.
Chauhan, S., et al., (2022). Health science reports, 5(4), e741.Study 3 - Male Fertility, Sexual Wellness and Testosterone in Men
Title: Efficacy and Safety of Eight-Week Therapy with Ashwagandha Root Extract in Improvement of Sexual Health in Healthy Men: Findings of a Prospective, Randomized, Double-Blind, Placebo-Controlled Study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved serum testosterone and dihydrotestosterone levels. There was also a significant improvement in semen volume, sperm count and sperm motility. In addition there was a significant increase in the level of sexual desire scores, number of satisfying sexual events, International Index of Erectile Function scores and improvement in overall quality of life. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving sexual wellness in men.
Efficacy and Safety of Eight-Week Therapy with Ashwagandha Root Extract in Improvement of Sexual Health in Healthy Men: Findings of a Prospective, Randomized, Double-Blind, Placebo-Controlled Study (Accepted for Publication).Study 4 - Sexual Wellness and Testosterone in Men
Title: Ashwagandha Root Extract Improves Sexual Health in Healthy Men: Findings of a Prospective, Randomized, Double-Blind, Placebo-Controlled Study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved total and free testosterone, sperm concentration, semen volume, sperm volume, level of sexual desire. There was also a significant increase in erectile function and quality of life. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving sexual wellness and testosterone in men.
Ashwagandha Root Extract Improves Sexual Health in Healthy Men: Findings of a Prospective, Randomized, Double-Blind, Placebo-Controlled Study (Under Peer Review).Study 5 - Sexual Wellness in Men (USA)
Title: Role of Ashwagandha Extract in Improving Sexual Health in Healthy Men: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study.
Conclusion: The study demonstrated that Ashwagandha root extract (600mg/day) significantly improved serum testosterone levels, level of sexual desire and Number of Satisfying Sexual Event scores. The supplementation was well-tolerated with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in improving sexual wellness and testosterone in men.
Role of Ashwagandha Extract in Improving Sexual Health in Healthy Men: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study (Under Peer review).Study 1 - Sexual Well-being in Women
Title: Efficacy and safety of ashwagandha root extract on sexual health in healthy women: findings of a prospective, randomized, double-blind, placebo-controlled study.
Conclusion: The study demonstrated a significant improvement in overall female sexual function index scores with ashwagandha root extract (600 mg/day). The supplementation also resulted in an increase in estrogen levels and a reduction in follicle-stimulating hormone levels.
Mutha A, et al., (2025) Cogent Psychology, 12:1, 2459467.Study 2 - Sexual Wellness in Women
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Effects of KSM-66 Ashwagandha® capsule (300 mg) on Sexual Health in Healthy Women.
Conclusion: The study demonstrated a significant improvement in overall female sexual function index scores with ashwagandha root extract (600 mg/day). The supplementation also resulted in an increase in estrogen levels and a reduction in progesterone hormone levels.
A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Effects of KSM-66 Ashwagandha® capsule (300 mg) on Sexual Health in Healthy Women (Accepted for Publication).Study 3 - Sexual Health in Women
Title: Effects of Ashwagandha Extract (Capsule KSM-66 300 mg) on Sexual Health in Healthy Women: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study.
Conclusion: The study demonstrated a significant improvement in overall female sexual function index scores with ashwagandha root extract (600 mg/day). The supplementation also resulted in an increase in estrogen levels.
Effects of Ashwagandha Extract (Capsule KSM-66 300 mg) on Sexual Health in Healthy Women: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study (Under Peer Review).Study 4 - Climacteric Symptoms in Perimenopausal Women
Title: The study demonstrated a significant reduction in the climacteric symptoms in women during perimenopause with Ashwagandha root extract (600mg/day). There was a significant increase in Estradiol levels and reduction in Follicle stimulating hormone, and luteinizing hormone levels.
Conclusion: The study demonstrated a significant improvement in overall female sexual function index scores with ashwagandha root extract (600 mg/day). The supplementation also resulted in an increase in estrogen levels and a reduction in progesterone hormone levels.
Gopal, S., et al., (2021). The journal of obstetrics and gynaecology research, 47(12), 4414–4425.Study 5 - Menopausal Symptoms in Women
Title: Efficacy And Safety of KSM66 Ashwagandha (Withania somnifera) Standardized Root Extract for Treatment of Menopausal symptoms in women: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study.
Conclusion: The study demonstrated a significant reduction in the menopausal symptoms in women with Ashwagandha root extract (600mg/day). A significant increase in estradiol levels was observed.
Efficacy And Safety of KSM66 Ashwagandha (Withania somnifera) Standardized Root Extract for Treatment of Menopausal symptoms in women: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study (Under Peer review) .Kids Wellness
Ashwagandha plays a crucial role in kids' wellness as a nootropic and adaptogen for calmness, sleep, focus, and cognition. KSM-66 Ashwagandha root extract is clinically proven to improve sleep, behaviour and emotional regulation, memory, concentration and focus in children.
Study 1
Title: Efficacy of Ashwagandha Root Extract in Treatment of Hyperactivity Disorder (ADHD) in Children Aged 5-12 Years.
Conclusion: The study demonstrated that Ashwagandha root extract (300mg/day) significantly reduced Inattention and Hyperactivity-Impulsivity domain scores, sleep disturbance, and anxiety in children. KSM-66 Ashwagandha did not show any significant effect on the hepatic and renal parameters. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in improving attention, sleep quality and symptoms of ADHD in children.
Efficacy of Ashwagandha Root Extract in Treatment of Hyperactivity Disorder (ADHD) in Children Aged 5-12 Years (Under Peer Review).Study 1
Title: A clinical assessment of the pharmacological effects of Ashwagandha root extract on parent-reported functions of cognition, behavior, sleep, fatigue, and executive function in children aged 6-12 years.
Conclusion: The study demonstrated that Ashwagandha root extract (300mg/day) significantly improved episodic memory, working memory, attention, executive function, and information processing speed, compared to the placebo group. Additionally, improved Sleep Disturbance Scale for Children scores, indicating better sleep-related behavior in children. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in enhancing children's memory, cognition, and sleep quality.
A clinical assessment of the pharmacological effects of Ashwagandha root extract on parent-reported functions of cognition, behavior, sleep, fatigue, and executive function in children aged 6-12 years (Under Peer Review).Study 2
Title: Efficacy of Ashwagandha Root Extract in Treatment of Hyperactivity Disorder (ADHD) in Children Aged 5-12 Years.
Conclusion: The study demonstrated that Ashwagandha root extract (300mg/day) significantly reduced Inattention and Hyperactivity-Impulsivity domain scores, sleep disturbance, and anxiety in children. KSM-66 Ashwagandha did not show any significant effect on the hepatic and renal parameters. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in improving attention, sleep quality, and symptoms of ADHD in children.
Efficacy of Ashwagandha Root Extract in Treatment of Hyperactivity Disorder (ADHD) in Children Aged 5-12 Years (Under Peer Review).Study 1
Title: A clinical assessment of the pharmacological effects of Ashwagandha root extract on parent-reported functions of cognition, behavior, sleep, fatigue, and executive function in children aged 6-12 years.
Conclusion: The study demonstrated that Ashwagandha root extract (300mg/day) significantly improved episodic memory, working memory, attention, executive function and information processing speed, compared to the placebo group. Additionally, improved Sleep Disturbance Scale for Children scores, indicating better sleep-related behavior in children. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in enhancing children's memory, cognition, and sleep quality.
A clinical assessment of the pharmacological effects of Ashwagandha root extract on parent-reported functions of cognition, behavior, sleep, fatigue, and executive function in children aged 6-12 years (Under Peer Review).Study 2
Title: Efficacy of Ashwagandha Root Extract in Treatment of Hyperactivity Disorder (ADHD) in Children Aged 5-12 Years.
Conclusion: The study demonstrated that Ashwagandha root extract (300mg/day) significantly reduced Inattention and Hyperactivity-Impulsivity domain scores, sleep disturbance, and anxiety in children. KSM-66 Ashwagandha did not show any significant effect on the hepatic and renal parameters. The supplementation was well-tolerated, with only mild adverse effects comparable to the placebo group and no serious adverse events. These findings suggest that Ashwagandha root extract is safe and effective in improving attention, sleep quality and symptoms of ADHD in children.
Efficacy of Ashwagandha Root Extract in Treatment of Hyperactivity Disorder (ADHD) in Children Aged 5-12 Years (Under Peer Review).Personal Care
Ashwagandha is one of the natural solutions which can work both inside and out. It is an adaptogenic herb that is known for its anti-inflammatory and antioxidant properties, which are beneficial for improving skin and hair health. KSM-66 Ashwagandha is clinically proven by both topical application and oral administration to reduce signs of skin aging like wrinkles and fine lines, and improve skin hydration and elasticity. It is also used in hair care products to strengthen hair and reduce hair loss.
Benefits of KSM-66
- help improve skin hydration and enhance skin texture
- help reduce hyperpigmentation and boost collagen production
- help improve hair density and reduce hair fall
- help nourish the scalp and reduce scalp irritation
Study 1
Title: A Study of Efficacy and Safety of Ashwagandha (Withania somnifera) Lotion on Facial Skin in Photoaged Healthy Adults.
Conclusion: The study demonstrated significant improvements with a standardized ashwagandha root extract lotion on skin health. Applied topically the lotion notably enhanced skin hydration, elasticity, and reduced signs of aging such as wrinkles and pigmentation. This study highlights ashwagandha's potential as a valuable component in skincare products for photo-aged facial skin.
Narra, K., et al., (2023). Cureus, 15(3), e36168.Study 1
Title: Effects of Withania somnifera root extract serum application on hair health in healthy adults: A prospective, double-blind, randomized, parallel, placebo-controlled study.
Conclusion: The study demonstrated significant improvements in hair health with the topical application of hair serum containing standardized ashwagandha root extract There was reduced hair loss and improvements in hair density, thickness, and growth. The study also recorded positive changes in emotional and functional scores related to hair health, highlighting ashwagandha's benefits for maintaining healthy hair.
Yerram, C., et al., (2023). Journal of Ayurveda and integrative medicine, 14(6), 100817.Study 1
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Ashwagandha Root Extract Capsule on Skin and Hair Health in Healthy Adults.
Conclusion: The study demonstrated significant improvement in skin and hair health with the oral administration of KSM-66 Ashwagandha (600mg/day). There was a significant improvement in skin hydration, quality of life, hair density and hair growth. The study provides evidence supporting the systemic benefits of ashwagandha for both skin and hair health.
A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Ashwagandha Root Extract Capsule on Skin and Hair Health in Healthy Adults (Under Peer Review).Study 1
Title: In-Vitro Skin Sensitization Study of KSM-66 Ashwagandha root extract by Human Cell LineActivation Test (h-CLAT) Assay on THP-1 cells.
Conclusion: The study demonstrated no significant increase in CD86 or CD54 expression, indicating that KSM-66 Ashwagandha root extract does not show any signs of skin irritation and sensitization and it can be concluded that the product is a non-sensitizer.
In-Vitro Skin Sensitization Study of KSM-66 Ashwagandha root extract by Human Cell LineActivation Test (h-CLAT) Assay on THP-1 cells (Under Peer Review).Study 2
Title: Determination of Ocular Irritation of KSM-66 Ashwagandha root extract Using HET-CAM Method.
Conclusion: In this study KSM-66 Ashwagandha root extract showed no ocular irritation effects in the HET-CAM assay, with scores equivalent to the negative control. This confirms that the extract is non-irritant to the eyes, ensuring its safety for use in ocular or near-eye products.
Determination of Ocular Irritation of KSM-66 Ashwagandha root extract Using HET-CAM Method (Under Peer Review).Study 3
Title: In-Vitro Skin Irritation of KSM-66 Ashwagandha root extract Powder using EPISKIN.
Conclusion: The study demonstrated that KSM-66 Ashwagandha root extract does not irritate the skin, maintaining high cell viability across all tested concentrations using the EPISKIN model. Consequently, it is considered to be safe for skin contact as it does not trigger irritation.
In-Vitro Skin Irritation of KSM-66 Ashwagandha root extract Powder using EPISKIN (Under Peer Review).Study 4
Title: In-Vitro Phototoxicity Study of KSM-66 Ashwagandha root extract by Neutral Red Uptake (NRU) Assay on 3T3 cells.
Conclusion: This study showed that KSM-66 Ashwagandha root extract does not exhibit any significant phototoxic effects on 3T3 cells. Therefore, it was concluded to be non-cytotoxic and non-phototoxic at the concentrations tested.
In-Vitro Phototoxicity Study of KSM-66 Ashwagandha root extract by Neutral Red Uptake (NRU) Assay on 3T3 cells (Under Peer Review).Pet Health
Ashwagandha stands out as a versatile botanical that can safely be incorporated into the diets of pets. This powerful herb offers a spectrum of benefits, including adaptogenic, immunomodulatory properties, antioxidant, anti-inflammatory, anti-aging, and thus supporting a vibrant, stress-free life for our beloved animals. KSM-66 Ashwagandha is clinically proven to reduce stress, anxiety, and improve gut health and immune function in companion animals.
Benefits of KSM-66 for Pets
- Enhance calmness, sleep, endurance.
- Increase cognitive health
- Reduce stress, anxiety, and cortisol
- Maintain hormonal balance
- Maintain a healthy and shiny coat and fur
- Help in overall wellbeing
- Support immunity, normal recovery, and joint health
Study 1
Title: Efficacy and Safety of Standardized Ashwagandha (Withania somnifera) Root Extract on Reducing Stress and Anxiety in Domestic Dogs: A Randomized Controlled Trial.
Conclusion: The study demonstrated that Ashwagandha root extract supplementation (15 mg/kg body weight) in dogs significantly reduced cortisol levels, fear and anxiety, and CBPI pain severity and pain interference domain scores, compared to placebo. The supplementation was well-tolerated with no adverse events reported. The findings suggest that Ashwagandha root extract is safe and effective in reducing stress, fear, and anxiety in dogs.
Kaur J, et al., (2022) Journal of Veterinary Behavior, 51, 8-15.Study 2
Title: Effects of ashwagandha (Withania somnifera) root extract on aging-related changes in healthy geriatric dogs: A randomized, double-blinded placebo-controlled study.
Conclusion: The study demonstrated that Ashwagandha root extract supplementation (15 mg/kg body weight) in geriatric dogs significantly reduced cortisol levels, interleukin-10 and Interferon-Y, when compared to placebo group. There was also a significant increase in Superoxide dismutase, Catalase and GSH concentrations. The supplementation was well-tolerated with no adverse events reported. The findings suggest that Ashwagandha root extract is safe and effective in reducing stress, and managing aging related changes in geriatric dogs.
Bharani, K. K.,et al., (2024). Veterinary medicine and science, 10(5), e1556.Study 3
Title: The role of Ashwagandha in modulating gut parameters in dogs—a randomized double-blind placebo-controlled trial.
Conclusion: The study demonstrated that Ashwagandha root extract supplementation (15 mg/kg body weight) in dogs significantly improved fecal scores, red blood cell counts, and hemoglobin levels. It also led to a significant increase in the levels of propionic acid and SCFA which are two important gut metabolites, known to have anti-inflammatory and gut barrier promoting activities.
Bharani KK, et al., (2025) Front. Vet. Sci. 11:1491989.Study 1
Title: Adaptogenic Ashwagandha root extract modulates inflammatory markers in feline stress management: a double-blind placebo-controlled clinical trial.
Conclusion: The study demonstrated that supplementation with Ashwagandha root extract (15 mg/kg body weight) in cats significantly reduced cortisol levels and inflammatory markers while also increasing hematological parameters. No detrimental changes were observed in liver and kidney function parameters. The supplementation was well-tolerated, with no adverse events reported. These findings suggest that Ashwagandha root extract is safe and effective in reducing stress and inflammation in cats.
Devarasetti, A. K., et al., (2024). Journal of Applied Animal Research, 52(1).Study 1
Title: Adaptogenic and Immunomodulatory Activity of Ashwagandha Root Extract: An Experimental Study in an Equine Model.
Conclusion: The study demonstrated that Ashwagandha root extract supplementation (2.5 gm/animal, 5 gm/animal, and 10 gm/animal per day) in horses exhibited a significant reduction in cortisol, interleukin-6, and epinephrine levels and an increase in hemoglobin, total erythrocyte count, total leucocyte counts, and lymphocyte percentage. The supplementation was well-tolerated with no adverse events reported. The findings suggest that Ashwagandha root extract is safe and has potent hemopoietic, antioxidant, adaptogenic, and possesses immune-modulatory properties.
Priyanka G et al., 2020, Frontiers in Veterinary Sciences 7:541112.Anti-Aging
Study 1
Title: Withania somnifera Root Extract Enhances Telomerase Activity in the Human HeLa Cell Line.
Conclusion: The study demonstrated an increase in the telomerase activity with KSM-66 Ashwagandha, thus portraying its anti-aging potential.
Raguraman, V. and Subramaniam, J. (2016) Advances in Bioscience and Biotechnology, 7, 199-204.Study 2
Title: Withania somnifera root extract extends lifespan of Caenorhabditis elegans.
Conclusion: The study demonstrated that the wild type worms showed around 20% lifespan extension when treated with KSM-66 Ashwagandha.
Kumar, R., Gupta, K., Saharia, K., Pradhan, D., & Subramaniam, J. R. (2013). Annals of neurosciences, 20(1), 13–16.Safety
Study 1
Title: Safety of Ashwagandha Root Extract: A Randomized, Placebo-Controlled, study in Healthy Volunteers.
Conclusion: The safety of Ashwagandha supplementation was conducted in healthy adults over 8 weeks in 80 participants who received either 300 mg of Ashwagandha or a placebo twice daily. The study assessed hematological, biochemical, and thyroid function parameters for safety. Secondary outcomes included clinical adverse events and vital parameters. Data were analyzed using the Wilcoxon signed-rank and Mann-Whitney U tests. No significant changes or abnormalities in vital signs, blood parameters, or thyroid function in either group were reported. No adverse events were reported. The study revealed the consumption of Ashwagandha root extract for 8 weeks was safe in both males and females volunteers.
Verma N, et al, (2021). Complementary Therapies in Medicine; 57:102642.Study 2
Title: Safety of 12-months administration of Ashwagandha (Withania Somnifera) Standardized Root Extract in Healthy Adults: A Prospective, Observational Study.
Conclusion: The long-term safety of KSM-66 Ashwagandha root extract over 12 months in 191 adults aged 18–65. Clinical assessments were conducted monthly, with laboratory tests at baseline, 6 months, and 12 months. No significant changes in hepatic, renal, or thyroid function, though ALT slightly increased and AST slightly decreased. Serum cortisol levels modestly declined, lipid and glucose levels remained stable, and testosterone significantly increased. Quality of life (SF-12) scores improved significantly, and 68.7% of participants showed overall clinical improvement, especially those aged ≥50 years. The study confirms the long-term safety of KSM-66 Ashwagandha for extended use.
Safety of 12-months administration of Ashwagandha (Withania Somnifera) Standardized Root Extract in Healthy Adults: A Prospective, Observational Study (Under Peer review).Study 3
Title: Safety and Efficacy of Ashwagandha (Withania somnifera) Root Extract (2000 mg/day) in Healthy Adults: A Prospective, Non-comparative Study.
Conclusion: The safety of KSM-66 Ashwagandha root extract at a high dose (2000 mg/day) in 100 healthy adults over 12 weeks was conducted. Primary outcomes included hematology, renal, liver, lipid, thyroid function, and glucose metabolism, while secondary outcomes assessed adverse events and quality of life (SF-12 scores). No significant changes in laboratory parameters, confirming a stable safety profile. Most participants (85%) reported no adverse events, with nausea being the most common mild side effect (7%). SF-12 scores improved by 16.04%, with greater benefits observed in women. The study concludes that high-dose Ashwagandha is safe for clinical use and enhances general health and quality of life.
Safety and Efficacy of Ashwagandha (Withania somnifera) Root Extract (2000 mg/day) in Healthy Adults: A Prospective, Non-comparative Study (Under peer review).Study 4
Title: Effects of Ashwagandha (Withania Somnifera) Supplementation on Body Composition and Blood Health Indices in Professional Wrestlers.
Conclusion: The safety of KSM-66 Ashwagandha in professional wrestlers (300 mg/day twice daily) over 8 weeks was conducted. There was a significant increase in fat-free mass and muscle mass, with a significant decrease in fat mass (both in absolute and relative terms) in both ashwagandha and placebo groups (main effect of time, p < 0.05). However, ashwagandha supplementation did not affect any of the body composition parameters. Ashwagandha supplementation did not significantly affect any hematological or biochemical blood parameters (p > 0.05 for main effect of group and interaction of time and group). However, the increase in creatine kinase activity during the study seemed to be more pronounced in the placebo group (post-hoc; p < 0.05) than in the ashwagandha group (post-hoc; p > 0.05). No significant changes in laboratory parameters, confirming a stable safety profile. KSM-66 is well tolerated and safe for professional wrestlers, and results indicate some potential for ashwagandha in improving muscle tissue recovery.
Długołęcka, B, et al. Polish Journal of Sport and Tourism, vol. 30, no. 4, Sciendo, 2023, pp. 26-32.Toxicological Studies on KSM-66 Ashwagandha Root Extract
A series of toxicology studies have been conducted to ensure the safety of KSM-66 across various models. These studies comply with GLP guidelines, ensuring a rigorous safety evaluation. These studies cover numerous toxicological evaluations, including acute, sub-acute, 90-day repeated dose toxicity, mutagenicity/genotoxicity, and prenatal developmental toxicity assessments. The following key studies are included:
Study 1
Title: Acute oral toxicity study of a single dose of 5000 mg/kg of KSM-66 Ashwagandha Root Extract (Withania somnifera) in Rats.
Conclusion: A recent acute oral toxicity study following OECD guideline 423 evaluated KSM-66 Ashwagandha root extract in Wistar rats. The rats, administered a single dose of 5000 mg/kg body weight, showed no signs of toxicity or morbidity over a 14-day observation period, with no adverse effects observed during necropsy. The findings established the LD50 cut-off value for the extract as greater than 5000 mg/kg, classifying it under Category-5 of the GHS, indicating a strong safety profile.
Acute oral toxicity study of KSM-66 Ashwagandha Root Extract (Withania somnifera) in Rats (Under Peer Review).Study 2
Title: Acute oral toxicity study of a single dose of 2000 mg/kg of KSM-66 Ashwagandha Root Extract (Withania somnifera) in Rats
Conclusion: In the study, an acute oral toxicity evaluation of KSM-66 Ashwagandha root extract was conducted on female Wistar rats according to OECD guideline 423. The rats, administered a single dose of 2000 mg/kg body weight, showed no signs of toxicity or organ damage over a 14-day observation period. The LD50 was determined to be greater than 5000 mg/kg, classifying the extract as Category-5 or unclassified by the Globally Harmonized Classification System (GHS), indicating a high safety profile.
Kalaivani, P et al., (2023).Toxicology reports, 12, 41–47.Study 3
Title: Acute Oral Toxicity Study of KSM-66 Ashwagandha Root Extract in Rats
Conclusion: In the study, an acute oral toxicity evaluation of KSM-66 Ashwagandha root extract was conducted on female Wistar rats according to OECD guideline 423. Initially the rats were orally administered in sequential doses of 5mg, 50mg, 300mg, and 2000mg via gavage to assess dose-response toxicity and no mortality or toxic symptoms were observed at any of the tested doses during the sighting study. Then 5 rats administered a single dose of 2000 mg/kg body weight, showed no signs of toxicity or organ damage over a 14-day observation period. These results indicate that KSM-66 Ashwagandha did not cause any adverse effects or toxicity in the treated animals. Therefore, KSM-66 Ashwagandha can be considered safe for rats up to a dose level of 2000mg/kg administered orally for 14 days.
Acute Oral Toxicity Study of KSM-66 Ashwagandha Root Extract in Rats (Completed)Study 4
Title: 28-Day Repeated Oral Dose Study of KSM-66 Ashwagandha Extract
Conclusion: The 28-day repeated oral dose toxicity study of KSM-66 Ashwagandha root extract was conducted on female Albino Wistar rats. KSM-66 Ashwagandha root extract was orally administered at doses of 500 mg/kg, 1000 mg/kg, and 2000 mg/kg for twenty-eight days alongside the control group. No mortality or symptoms of toxicity were observed at any dose level. An increase in body weight gain was noted in both male and female rats, but feed intake remained unchanged compared to the control group. The study concluded that the Ashwagandha extract was safe and non-toxic at doses up to 2000 mg/kg when given orally daily for 28 days.
28-Day Repeated Oral Dose Study of KSM-66 Ashwagandha Extract (Completed)Study 5
Title: Acute and 28-days Repeated dose Genotoxicity Study of KSM-66 Ashwagandha in Albino Rats
Conclusion: The acute and subacute genotoxicity studies of KSM-66 Ashwagandha root extract in Albino Wistar rats were conducted according to the OECD guidelines 420 and 407, respectively. KSM-66 Ashwagandha was administered at 500, 1000, and 2000 mg/kg body weight/day for acute and 250, 500, and 1000 mg/kg body weight/day for subacute studies. No significant increase in % tail DNA was observed at any dose level (acute: 500–2000 mg/kg; subacute: 250–1000 mg/kg/day). The extract was found to be non-genotoxic and safe at all tested doses.
Acute and 28-days Repeated dose Genotoxicity Study of KSM-66 Ashwagandha in Albino Rats (Completed)Study 6
Title: Subacute Toxicity of KSM-66 Ashwagandha root extract in Wistar Rats
Conclusion: The subacute toxicity assessment of KSM-66 Ashwagandha root extract in Wistar rats was conducted according to the Modified OECD guidelines- 407. KSM-66 Ashwagandha root extract was administered orally once daily for 28 days at 200, 400, and 800 mg/kg body weight. No signs of intoxication and no changes in blood biochemistry were observed. Histopathological changes in organs were within normal limits. The authors concluded that no signs of intoxication were evident, vital liver parameters remained stable, no abnormality was observed in general parameters, and all the animals survived till the 28-day study period.
Langade, D., et al., (2023). Toxicology reports, 11, 389–395.Study 7
Title: 90-Day Repeated Dose Oral Toxicity Study of KSM-66 Ashwagandha Root Extract in Wistar Rats
Conclusion: The 90-day repeated dose oral toxicity of KSM-66 Ashwagandha root extract in 100 nulliparous and non-pregnant Wistar Albino rats was conducted according to the Modified OECD guidelines 408. KSM-66 Ashwagandha root extract was administered orally once for 90 days at 500, 1000, and 2000 mg/kg body weight. No morbidity, mortality, or toxicity signs were observed. Ophthalmic, sensory, and motor exams showed no changes. Body weight, food intake, hematology, biochemistry, and thyroid hormones remained unaffected. Liver histology was normal even at the highest dose. The NOAEL was established at 2000 mg/kg, confirming the extract's safety for oral use.
Kalaivani, P et al., (2023).Toxicology reports, 11, 189–198.Study 8
Title: Two-Weeks Dose Range-Finding Study of KSM-66 Ashwagandha root extract by oral route in Wistar rats
Conclusion: The two-Weeks Dose Range-Finding study of KSM-66 Ashwagandha root extract evaluated in 40 nulliparous, non-pregnant Wistar rats at doses of 500, 1000, and 2000 mg/kg showed no mortality, morbidity, or clinical signs of toxicity were observed. Body weight, feed intake, organ weights, and necropsy findings showed no test item-related effects. The extract was well tolerated up to 2000 mg/kg, confirming its short-term safety.
Kalaivani et al., (2024). International Journal of Medical and Pharmaceutical Research. 5:1; 153-164.Study 9
Title: Bacterial Reverse Mutation Test with KSM-66 Ashwagandha root extract in Salmonella Typhimurium Strains
Conclusion: The bacterial reverse mutation test with KSM-66 Ashwagandha root extract in five Salmonella typhimurium strains conducted following OECD Guideline Number 471 showed no cytotoxicity up to 5 mg/plate. In both trials, with and without metabolic activation, there was no increase in revertant colonies, and the bacterial lawn remained normal. The extract showed no mutagenic potential and was non-mutagenic up to 5 mg/plate under the test conditions.
Kalaivani, P et al., (2023).Toxicology reports, 12, 41–47.Study 10
Title: In Vitro Chromosomal Aberration Test with KSM-66 Ashwagandha root extract in cultured human lymphocytes
Conclusion: The Invitro Chromosomal Aberration Test on KSM-66 Ashwagandha root extract, done according to OECD Guideline 473, found no cell damage or major changes in chromosomes in human lymphocytes at levels up to 2 mg/ml, whether or not metabolic activation was present. Positive controls confirmed that the test was valid. Positive controls confirmed test validity. The extract was concluded to be non-clastogenic under the tested conditions.
Kalaivani, P et al., (2023).Toxicology reports, 12, 41–47.Study 11
Title: Thyroid Toxicity evaluation of KSM-66 Ashwagandha root extract in zebrafish embryos
Conclusion: The thyroid safety of KSM-66 Ashwagandha root extract in transgenic zebrafish embryos was evaluated using a thyroglobulin reporter gene fluorescence assay. Embryos were exposed to 1–50 µg/ml concentrations. No significant fluorescence intensity changes were observed on day 5 post-fertilization, indicating no goitrogenic effects. The extract was found to be non-toxic and safe for thyroid health.
Naseem et al., 2023. International Journal of Medical and Pharmaceutical Research. 4:5; 341-346.Study 12
Title: In vivo Mammalian Erythrocyte Micronucleus Test with KSM-66 Ashwagandha root extract in Swiss Albino mice
Conclusion: The In Vivo Mammalian Erythrocyte Micronucleus Test, conducted per OECD Guideline 474, assessed the clastogenic potential of KSM-66 Ashwagandha root extract in Swiss albino mice. No mortality, morbidity, or bone marrow toxicity was observed up to 2000 mg/kg. There was no significant decrease in the P/E ratio or evidence of cytogenetic damage. The extract was concluded to be non-clastogenic under the tested conditions.
Kalaivani, P et al., (2023).Toxicology reports, 12, 41–47.Study 13
Title: Reproduction and Developmental Toxicity Screening Study of KSM-66 Ashwagandha Root Extract by Oral Route in Wistar Rats
Conclusion: The reproductive and developmental toxicity study of KSM-66 Ashwagandha root extract in Wistar rats was conducted following OECD Guideline 421. Wistar rats received oral doses of 500, 1000, and 2000 mg/kg body weight. Males were treated for up to 4 weeks and females for 63 days, covering pre-mating to lactation. No treatment-related mortality or abnormal clinical signs were observed in adults or pups. Reproductive parameters, hormonal levels, organ weights, and histopathology showed no significant changes across groups. The NOAEL was established at 2000 mg/kg, confirming the extract's safety for reproductive and developmental health.
Reproduction and Developmental Toxicity Screening Study of KSM-66 Ashwagandha Root Extract by Oral Route in Wistar Rats (Under Peer Review)