KSM-66 Ashwagandha    

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Clinical studies on KSM-66 :

Research on KSM-66 Ashwagandha

Ixoreal is the industry leader in clinical trials and basic research investigating the effectiveness of ashwagandha. KSM-66 has been evaluated in 13 “Gold Standard” human clinical trials. It collaborates with major academic and research institutes. All of Ixoreal-partnered clinical studies follow gold standards of substantiation: randomized, double-blind, placebo-controlled designs.

For a herb to operate at a systemic level, it needs a complex blend of phytochemicals with a wide range of actions on the human body. Ashwagandha is one of the very few herbs in the world with a complex blend of this type. As ashwagandha operates at the systemic level, it has 20+ distinct applications described in herbal medicine textbooks.

Published Clinical studies

1. KSM-66 ASHWAGANDHA FOR STRESS AND ANXIETY

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. Chandrasekhar, K., Kapoor, J., & Anishetty, S. (2012). Indian journal of psychological medicine, 34(3), 255.

Results: The treatment group that was given the high-concentration full-spectrum Ashwagandha root extract exhibited a significant reduction (P<0.0001) in scores on all the stress-assessment scales on Day 60, relative to the placebo group. The serum cortisol levels were substantially reduced (P=0.0006) in the Ashwagandha group, relative to the placebo group. The adverse effects were mild in nature and were comparable in both the groups. No serious adverse events were reported.

Conclusion: The findings of this study suggest that a high-concentration full-spectrum Ashwagandha root extract safely and effectively improves an individual’s resistance towards stress and thereby improves self-assessed quality of life.

2. KSM-66 ASHWAGANDHA FOR TESTOSTERONE MALE SEXUAL FUNCTION

Clinical Evaluation of the Spermatogenic Activity of the Root Extract of Ashwagandha (Withania somnifera) in Oligospermic Males: A Pilot Study Ambiye, V. R., Langade, D., Dongre, S., Aptikar, P., Kulkarni, M., & Dongre, A. (2013).  Evidence-Based Complementary and Alternative Medicine, 2013.

Results: There was a 167% increase in sperm count (9.59 ± 4.37 × 106/mL to 25.61 ± 8.6 × 106/mL; ), 53% increase in semen volume (1.74 ± 0.58 mL to 2.76 ± 0.60 mL; ), and 57% increase in sperm motility (18.62 ± 6.11% to 29.19 ± 6.31%; ) on day 90 from baseline. The improvement in these parameters was minimal in the placebo-treated group. Furthermore, a significantly greater improvement and regulation were observed in serum testosterone levels with the Ashwagandha treatment as compared to the placebo (p<0.001).

Conclusion:The present study adds to the evidence on the therapeutic value of Ashwagandha (Withania somnifera), as attributed in Ayurveda for the treatment of oligospermia leading to infertility.

3. KSM-66 ASHWAGANDHA FOR CARDIORESPIRATORY ENDURANCE

Efficacy of Ashwagandha (Withania somnifera [L.] Dunal) in improving cardiorespiratory endurance in healthy athletic adults Choudhary, B., Shetty, A., & Langade, D. G. (2015). Ayu, 36(1), 63.

Results: There was a greater increase from baseline (P < 0.0001) in the mean VO2 max with KSM-66 Ashwagandha (n = 24) compared to placebo (n = 25) at 8 weeks (4.91 and 1.42, respectively) and at 12 weeks (5.67 and 1.86 respectively). The QOL scores for all subdomains significantly improved to a greater extent in the Ashwagandha group at 12 weeks compared to placebo
(P < 0.05).

Conclusion: The findings suggest that Ashwagandha root extract enhances the cardiorespiratory endurance and improves QOL in healthy athletic adults.

4. KSM-66 ASHWAGANDHA FOR TESTOSTERONE, MUSCLE STRENGTH AND RECOVERY

Examining the effect of Withania somnifera supplementation on muscle strength and recovery: a randomized controlled trial Wankhede, S., Langade, D., Joshi, K., Sinha, S. R., & Bhattacharyya, S. (2015). Journal of the International Society of Sports Nutrition, 12(1), 43.

Results: Compared to the placebo subjects, the group treated with ashwagandha had significantly greater increases in muscle strength on the bench-press exercise (Placebo: 26.4 kg, 95 % CI, 19.5, 33.3 vs. Ashwagandha: 46.0 kg, 95 % CI 36.6, 55.5; p = 0.001) and the leg-extension exercise (Placebo: 9.8 kg, 95 % CI, 7.2,12.3 vs. Ashwagandha: 14.5 kg, 95 % CI, 10.8,18.2; p = 0.04), and significantly greater muscle size increase at the arms (Placebo: 5.3 cm2, 95 % CI, 3.3,7.2 vs. Ashwagandha: 8.6 cm2, 95 % CI, 6.9,10.8; p = 0.01) and chest (Placebo: 1.4 cm, 95 % CI, 0.8, 2.0 vs. Ashwagandha: 3.3 cm, 95 % CI, 2.6, 4.1; p < 0.001). Compared to the placebo subjects, the subjects receiving ashwagandha also had significantly greater reduction of exercise-induced muscle damage as indicated by the stabilization of serum creatine kinase (Placebo: 1307.5 U/L, 95 % CI, 1202.8, 1412.1, vs. Ashwagandha: 1462.6 U/L, 95 % CI, 1366.2, 1559.1; p = 0.03), significantly greater increase in testosterone level (Placebo: 18.0 ng/dL, 95 % CI, -15.8, 51.8 vs. Ashwagandha: 96.2 ng/dL, 95 % CI, 54.7, 137.5; p = 0.004), and a significantly greater decrease in body fat percentage (Placebo: 1.5 %, 95 % CI, 0.4 %, 2.6 % vs. Ashwagandha: 3.5 %, 95 % CI, 2.0 %, 4.9 %; p = 0.03).

Conclusion: This study reports that ashwagandha supplementation is associated with significant increases in muscle mass and strength and suggests that ashwagandha supplementation may be useful in conjunction with a resistance training program.

5. KSM-66 ASHWAGANDHA FOR FEMALE SEXUAL FUNCTION

Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Improving Sexual Function in Women: A Pilot Study Dongre, S., Langade, D., & Bhattacharyya, S. (2015). BioMed research international, 2015.

Results:The analysis indicates that treatment with HCARE leads to significantly higher improvement, relative to placebo, in the FSFI Total score (p < 0.001), FSFI domain score for “arousal” (p < 0.001), “lubrication” (p < 0.001), “orgasm” (p = 0.004), and “satisfaction” (p < 0.001), and also FSDS score (p < 0.001) and the number of successful sexual encounters (p < 0.001) at the endof the treatment.

Conclusion: This study demonstrated that oral administration of HCARE may improve sexual function in healthy women.

6. KSM-66 ASHWAGANDHA FOR STRESS AND WEIGHT MANAGEMENT

Body Weight Management in Adults Under Chronic Stress Through Treatment With Ashwagandha Root Extract: A Double-Blind, Randomized, Placebo-Controlled Trial Choudhary, D., Bhattacharyya, S., & Joshi, K. (2017). Journal of evidence-based complementary & alternative medicine, 22(1), 96-106.

Results: KSM-66 Ashwagandha caused significant reduction in Perceived Stress among the subjects. At the end of the study, KSM-66 Ashwagandha produced a 32.74% reduction in PSS scores from the baseline compared to placebo group. KSM-66 Ashwagandha reduced desire or cravings for food in the study subjects. The FCQ scores for Planning, Positive and Negative reinforcement, Lack of control, Emotion and Environment domains were reduced significantly (P < 0.05) in the Ashwagandha supplemented subjects. A statistically significant (P < 0.05) decrease of 22.2% was observed in serum cortisol (a stress hormone) levels as a result of KSM-66 Ashwagandha supplementation compared to placebo group. KSM-66 Ashwagandha supplementation resulted in a 3.0% and 2.9% reduction in bodyweight (P < 0.05) and BMI (P < 0.05) respectively. Supplementation with KSM-66 Ashwagandha resulted in a significant (P < 0.05) increase in OHQ scores and a significant (P < 0.05) reduction in TFEQ scores for ‘Uncontrolled’ and ‘Emotional Eating behavior’ compared to placebo group.

Conclusion: The outcome of this study suggests that Ashwagandha root extract can be used for body weight management in adults under chronic stress.

7. KSM-66 ASHWAGANDHA FOR MEMORY AND COGNITION

Efficacy and Safety of Ashwagandha (Withania somnifera (L.) Dunal) Root Extract in Improving Memory and Cognitive Functions Choudhary, D., Bhattacharyya, S., & Bose, S. (2017). Journal of Dietary Supplements, 1-14. Chicago

Results: After eight weeks of study, the ashwagandha treatment group demonstrated significant improvements compared with the placebo group in both immediate and general memory, as evidenced by Wechsler Memory Scale III subtest scores for logical memory I (p = 0.007), verbal paired associates I (p = 0.042), faces I (p = 0.020), family pictures I (p = 0.006), logical memory II (p = 0.006), verbal paired associates II (p = 0.031), faces II (p = 0.014), and family pictures II (p = 0.006). The treatment group also demonstrated significantly greater improvement in executive function, sustained attention, and information-processing speed as indicated by scores on the Eriksen Flanker task (p = 0.002), Wisconsin Card Sort test (p = 0.014), Trail-Making test part A (p = 0.006), and the Mackworth Clock test (p = 0.009).

Conclusion: Ashwagandha may be effective in enhancing both immediate and general memory in people with MCI as well as improving executive function, attention, and information processing speed.

8. KSM-66 ASHWAGANDHA FOR ANTI-AGING

Withania somnifera root extract extends lifespan of Caenorhabditis elegans Kumar, R., Gupta, K., Saharia, K., Pradhan, D., & Subramaniam, J. R. (2013). Annals of neurosciences, 20(1), 13.

Results: Strangely, while there was no effect on the wild type worms, the mutant for the human nicotinic acetylcholine receptor, nAchR, α7 equivalent, acr-16, showed around ~20% lifespan extension when treated with PI-RE.

Conclusion: Ashwagandha extends the lifespan of C. elegans.

9. KSM-66 ASHWAGANDHA AND TELOMERASE ACTIVITY

Withania somnifera Root Extract Enhances Telomerase Activity in the Human HeLa Cell Line Raguraman, V., & Subramaniam, J. R. (2016). Advances in Bioscience and Biotechnology, 7(04), 199.

Results:It has been observed that, KSM-66 Ashwagandha increased telomerase activity through TRAP assay, with highest enhancement of ~45% at 10-50μg concentration.

Conclusion: Ashwagandha root extract has the anti-aging inducing potential

Please contact us at info@ixoreal.com for more information on ongoing studies, published papers and technical reports on KSM-66.