Sleep Quality I

Adaptogenic and anxiolytic effects of ashwagandha root extract in healthy adults: A double-blind, randomized, placebo-controlled clinical trial.
Salve, J., Pate, S., Debnath, K. & Langade, D. (2019). Cureus, 11(12), e6466.

Results:
This ten-week, randomized, double-blind, placebo-controlled clinical trial with 58 participants showed that daily intake of 600 mg of KSM-66 improved sleep quality, reduced the time to fall asleep, and increased total sleep duration.

The study examined the effects of an aqueous root extract of Ashwagandha in 58 participants suffering from stress and anxiety. A significant reduction in PSS (Perceived Stress Scale) scores was observed with both 250 mg and 600 mg of Ashwagandha per day. Serum cortisol levels also decreased significantly at both doses: 250 mg/day and 600 mg/day. Compared to the placebo group, participants taking Ashwagandha showed a significant improvement in sleep quality.

Sleep Quality II

Clinical evaluation of the pharmacological effect of Ashwagandha root extract on sleep in healthy volunteers and patients with insomnia: A double-blind, randomized, parallel, placebo-controlled study.
Langade, D., Thakare, V., Kanchi, S. & Kelgane, S. (2020). Journal of Ethnopharmacology, 264:113276.

Results:
At the end of the 8-week study, the group supplemented with Ashwagandha root extract showed significant improvements in sleep parameters in both healthy participants and patients with insomnia. The improvements were more pronounced in the insomnia patients than in the healthy participants.

The analysis of variance (ANOVA) confirmed a significant improvement in the following areas:

• Sleep latency (SOL)
• Hamilton Anxiety Scale (HAM-A)
• Mental alertness in the morning
• Sleep quality

A two-factor ANOVA also confirmed:

• Sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) were the most improved parameters
• Total sleep time and wake time after first falling asleep also showed significant improvements

This study confirms that Ashwagandha root extract can improve sleep quality and help treat insomnia. The extract was well tolerated by all participants, regardless of their health status and age.

Menopause/menopausal symptoms

Effect of an Ashwagandha (Withania Somnifera) root extract on menopausal symptoms in perimenopausal women: A randomized, double-blind, placebo-controlled study.
Gopal, S., Ajgaonkar, A., Kanchi, P., Kaundinya, A., Thakare, V., Chauhan, S. & Langade, D. (2021). J. Obstet. Gynaecol. Research, 47(12), 4414–4425.

Results:

Compared to the placebo group, supplementation with Ashwagandha was associated with a statistically significant reduction in the total MRS score (Menopause Rating Scale). This reduction was particularly evident in the following areas:

• Psychological symptoms
• Somato-vegetative symptoms
• Urogenital symptoms

In addition, the intake of Ashwagandha led to a significant reduction in the total MENQoL score (Menopause-Specific Quality of Life).

Other significant changes compared to the placebo group:

• Increase in serum estradiol levels
• Reduction of serum FSH levels
• Reduction of serum LH levels

The results of this 8-week study provide initial evidence that ashwagandha root extract is safe and effective in relieving menopausal symptoms during perimenopause. The mechanism behind this effect may be the reduction of psychological symptoms and the increase in estradiol levels.

Sleep quality & anxiety

Efficacy and safety of Ashwagandha (Withania somnifera) root extract in insomnia and anxiety: A double-blind, randomized, placebo-controlled study.
Langade, D., Kanchi, S., Salve, J., Debnath, K. & Ambegaokar, D. (2019). Cureus, 11(9), e5797.

Results:

· The Sleep latency (SOL) improved in both the Ashwagandha and placebo groups after five and ten weeks. However, after ten weeks, sleep latency was significantly shorter than in the placebo group.

• The Sleep efficiency (SE) improved significantly with Ashwagandha
• Sleep quality: The improvement was significantly greater in the Ashwagandha group than in the placebo group.
• Further significant improvements were found in all other sleep parameters, including:
• Sleep latency (SOL)
• Sleep efficiency (SE)
• Pittsburgh Sleep Quality Index (PSQI)
• Hamilton Anxiety Scale (HAM-A) for anxiety

Ashwagandha root extract is a natural remedy with sleep-promoting potential that is well tolerated. It improves sleep quality and sleep latency in patients with insomnia at a dosage of 300 mg twice daily.

Hypothyroidism

Efficacy and safety of Ashwagandha root extract in patients with subclinical hypothyroidism: A double-blind, randomized, placebo-controlled study.
Sharma, A.K., Basu, I. & Singh, S. (2017). The Journal of Alternative and Complementary Medicine.

Results:
Ashwagandha treatment resulted in a significant normalization of thyroid hormone levels TSH, T3, and T4 over the entire study period of eight weeks.

Cognitive function and memory

Efficacy and safety of Ashwagandha (Withania somnifera (L.) Dunal) root extract for improving memory and cognitive functions
Choudhary, D., Bhattacharyya, S. & Bose, S. (2017). Journal of Dietary Supplements, 1-14.

Results:

In an eight-week study involving 50 adults, daily intake of 600 mg of KSM-66 led to significant improvements in areas such as immediate and general memory, attention, and information processing speed. This was demonstrated by the Wechsler Memory Scale III. Executive function, sustained attention, and information processing speed also improved significantly.

Ashwagandha may therefore improve both immediate and general memory in individuals with mild cognitive impairment (MCI) and may also increase executive functions, attention, and information processing speed.

Weight management in chronic stress

Weight management in adults under chronic stress through treatment with Ashwagandha root extract: A double-blind, randomized, placebo-controlled study
Choudhary, D., Bhattacharyya, S. & Joshi, K. (2017). Journal of Evidence-Based Complementary & Alternative Medicine, 22(1), 96-106.

Results:

In this eight-week study of 52 overweight adults, daily intake of 600 mg of KSM-66 resulted in significant reductions in body weight and body mass index (BMI), as well as improved eating habits.

• KSM-66 Ashwagandha led to a significant reduction in perceived stress (PSS scores). At the end of the study, the PSS score decreased by 32.74% compared to the placebo group.
• Ashwagandha reduced food cravings and binge eating. FCQ scores for planning, positive and negative reinforcement, loss of control, emotions, and environmental stimuli decreased significantly in the ashwagandha group.
• Serum cortisol (stress hormone) levels decreased by 22.2% compared to the placebo group.
• Taking KSM-66 Ashwagandha resulted in a reduction in body weight by 3.0% and BMI by 2.9%.
• In addition, there was a significant improvement in well-being (OHQ scores) and a reduction in uncontrolled and emotional eating behavior (TFEQ scores) compared to the placebo group.

The results of the study suggest that Ashwagandha root extract can be used as a natural support for weight management in adults under chronic stress.

Strength training

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

Results:

Compared to the placebo participants, the ashwagandha-treated group had significantly greater increases in bench press muscle strength and significantly greater increases in arm and chest muscle girth. Compared to the placebo participants, participants receiving ashwagandha also showed a significantly greater reduction in exercise-induced muscle damage, as measured by stabilization of serum creatine kinase.

Anti-Aging/Longevity

Withania somnifera root extract increases telomerase activity in the human HeLa cell line
Raguraman, V. & Subramaniam, J.R. (2016). Advances in Bioscience and Biotechnology, 7(04), 199.

Results:
The study showed that KSM-66 Ashwagandha increased telomerase activity in the TRAP assay. The greatest increase was ~45% at a concentration of 10–50 μg.

Male sexual health

Clinical evaluation of spermatogenic activity of Ashwagandha (Withania somnifera) root extract in oligospermic men: A pilot study Ambiye, VR, Langade, D., Dongre, S., Aptikar, P., Kulkarni, M., & Dongre, A. (2013). Evidence-based complementary and alternative medicine, 2013.

Results:

In a study of 46 men with oligospermia, daily intake of 675 mg of KSM-66 for 90 days resulted in a 167% increase in sperm count, a 53% increase in ejaculate volume, and a 57% improvement in sperm motility. A significant increase in testosterone levels was also observed.

Stress & Anxiety

A prospective, randomized, double-blind, placebo-controlled study of the safety and efficacy of a high-strength, 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:

This double-blind, placebo-controlled study involving 64 adults showed that daily intake of 300 mg of KSM-66 for 60 days resulted in a significant reduction in stress and anxiety. A significant decrease in cortisol levels was also observed.

The treatment group receiving the highly concentrated full-spectrum ashwagandha root extract showed significant reductions in scores on all stress assessment scales compared to the placebo group on day 60. Serum cortisol levels were significantly reduced in the ashwagandha group compared to the placebo group.

Cardiorespiratory endurance

A study of 49 healthy, physically active adults showed that daily intake of 600 mg KSM-66 for 12 weeks significantly increased maximum oxygen uptake (VO2 max), indicating improved cardiorespiratory endurance.