The adaptogenic herb contains the compound triethylene glycol, which may promote sleep induction and has been shown to improve both quantity and quality of sleep in animal studies.
The purpose of the study was to determine the efficacy and safety of ashwagandha root extract in patients with insomnia and anxiety. The double-blind, randomized, placebo-controlled human clinical study found that by Ixoreal Biomed'S KSM-66 can be a safe, effective solution to insomnia and the anxiety that often comes with it.
The study was conducted at Prakruti Hospital, Kalwa, Maharashtra, India. A total of 60 participants were randomly divided into two groups: test (n = 40) and placebo (n = 20) in a randomization ratio of 2:1. Test product was a capsule containing highest concentration full-spectrum Ashwagandha root extract 300 mg, and the placebo was an identical capsule containing starch. Both capsules were given twice a day for 10 weeks. Sleep actigraphy was used to assess sleep onset latency (SOL), total sleep time (TST), sleep efficiency (SE) and wake after sleep onset (WASO). Other assessments were total time in bed (sleep log), mental alertness on rising, sleep quality, Pittsburgh Sleep Quality Index (PSQI), and Hamilton Anxiety Rating Scale (HAM-A).
A total of 85 participants were screened and assessed for eligibility initially, out of which, 25 participants failed eligibility criteria. The remaining 60 participants with insomnia underwent randomization and were allocated to two groups: experimental and control group in a ratio of 2:1. Two participants (one from each group) withdrew from the study. The analysis was continued using the data for the remaining 58 participants through per-protocol (PP) analysis.
The baseline parameters were similar in the two groups at baseline. The sleep onset latency was improved in both test and placebo at five and 10 weeks. However, the SOL was significantly shorter after 10 weeks compared to the placebo. Also, significant improvement in SE scores was observed with ashwagandha after 10 weeks. Similarly, significant improvement in sleep quality was observed with test compared to placebo. Significant improvement was also observed in all other sleep parameters, i.e., SOL, SE, PSQI and anxiety (HAM-A scores) with ashwagandha root extract treatment for 10 weeks.
Ashwagandha root extract is a natural compound with sleep-inducing potential, well tolerated and improves sleep quality and sleep onset latency in patients with insomnia at a dose of 300 mg extract twice daily. It could be of potential use to improve sleep parameters in patients with insomnia and anxiety, but further large-scale studies are needed.
"The new study corroborates the use of Ashwagandha root extract as a first-class adaptogen that helps promote restful sleep and reduce anxiety," says ethnobotanist, Medicine Hunter Christopher Kilham, who served for 14 years as Explorer in Residence at the University of Massachusetts, Amherst.
Americans are sleep deprived
"We know that Americans are not getting enough sleep. Ashwagandha offers a simple, safe and natural way to achieve deep sleep for badly needed rest and repair, without drowsiness or negative effects. You simply do not need to resort to potentially harmful or addictive drugs to achieve healthy sleep,” added Kilham.
Ashwagandha is ranked in the “top 40” list among all herbs in the marketplace. According to Herbalgram’s latest market report, the botanical ranked #7 in the natural channel and #34 in mass market—a whopping 166% increase from the previous year. A recent analysis from Consumer Reports found that of the more than 4,000 US adults surveyed, 27% of them said they can’t fall asleep or stay asleep most nights. Analysts predict consumers to spend over $101.9 billion in the sleep aid category by 2023.
Ixoreal CEO Kartikeya Baldwa said sleep deprivation is tied to an increased risk of numerous chronic diseases: "Sleep is of course critical to well-being and healthy functioning. Published research has associated insomnia with chronic diseases such as obesity, type 2 diabetes, cardiovascular disease, neurological issues, mood swings, and increased mortality."
11(9): e5797 (2019) doi: 10.7759/cureus.5797
Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Insomnia and Anxiety: A Double-blind, Randomized, Placebo-controlled Study
Authors: Langade D, et al.