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

Abstract

Background Ashwagandha is an excellent adaptogen that is being used since ancient times in Ayurvedic medicine. Traditionally, it is used for various ailments and general well-being, including the treatment of geriatric patients. Managing quality of life (QoL) remains a challenge for the elderly population, especially joint pain management, sleep, and general well-being. With a growing global elderly population, QoL management with efficient medication and supplementation is the major healthcare requirement. Objective The objective of this study was to assess the safety, efficacy, and tolerability of Ashwagandha (Withania somnifera (L.) Dunal.) root extract on the improvement of general health and sleep in elderly people. Methods This 12-week, prospective, randomized, double-blind, placebo-controlled study was conducted on individuals of either gender aged between 65-80 years. Participants were randomized to receive Ashwagandha root extract at a dose of 600 mg/day (n = 25) orally, or identical placebo capsules with the same dose (n = 25) for 12 weeks. Efficacy was assessed using the WHOQOL-BREF questionnaire, sleep quality, mental alertness on rising, and Physician's Global Assessment of Efficacy to Therapy (PGAET). The safety and tolerability were assessed using the clinical adverse events reporting and Patient's Global Assessment of Tolerability to Therapy (PGATT).

Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis

“…We included five trials with a total of 400 participants [45,[53][54][55][56]. Table 1 further describes the studies included.…”

“…Out of the five trials, one trial declared that their study was partially sponsored by the manufacturer [45]. All trials were conducted in India [45,[53][54][55][56]. Three of the trials recruited participants from outpatient clinics [54][55][56], one trial recruited through phone call [45], and one trial did not mention the method of recruitment [53].…”

“…All trials were conducted in India [45,[53][54][55][56]. Three of the trials recruited participants from outpatient clinics [54][55][56], one trial recruited through phone call [45], and one trial did not mention the method of recruitment [53]. The five trials included in this meta-analysis comprised of two trials with 210 healthy adults [45,53], one trial with 50 healthy elderly over 60 years old [55], one trial with 60 adults diagnosed with insomnia based on DSM-IV [54], and one trial that included two groups of participants which were 40 healthy adults, and 40 adults diagnosed with insomnia based on DSM-IV [56].…”

Effects of Ashwagandha (Withania somnifera) on Physical Performance: Systematic Review and Bayesian Meta-Analysis

“…More research comparing sex differences is needed, considering that it seems the production of testosterone derivatives (e.g., DHEA) from withanolides may lead to important differences. In this sense, the positive benefits on the hormonal profile (DHEA-S and testosterone) in overweight men over 50 s [ 65 ], on the immediate and general memory, executive function, attention and speed of information processing in subjects aged 50 with mild cognitive impairment [ 73 ], and on the quality of life, mental alertness and quality of sleep in healthy men and women over 70 s [ 74 ], makes the Ashwagandha root extract a nutritional alternative to optimize physical condition, bone and muscle health while preventing loss of muscle mass and strength in elderly.…”

Medicinal Plants for Insomnia Related to Anxiety: An Updated Review

“…A similar trial performed by Langade et al confirmed that ashwagandha can be used as an anxiolytic as well as for treating insomnia and enhancing sleep quality compared to a placebo [73]. Kelgane et al studied whether an extract of ashwagandha could be used in the elderly for general health and sleep quality, with the outcomes, as measured with different scales, demonstrating that ashwagandha supplementation could be an effective alternative to counter issues associated with aging, including sleep quality and mental alertness [74]. Deshpande et al showed improved sleep quality in healthy patients suffering from nonrestorative sleep after treatment with a standardized extract of ashwagandha [75].…”