A Standardized Withania somnifera (Linn.) Root Extract with Piperine Alleviates the Symptoms of Anxiety and Depression by Increasing Serotonin Levels: A Double-Blind, Randomized, Placebo-Controlled Study
Majeed M, Nagabhushanam K, Murali A, Vishwanathan DT, Mamidala RV, Mundkur L
Journal of integrative and complementary medicine · 18 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2023-10-25 · J Integr Complement Med · vol. 30 · issue 5 · pp. 459–468
- Publisher
- Mary Ann Liebert, Inc.
- Cited
- 24 citations · more than 97% of similar papers · 7.6× the field average
- Impact
- Top 10% most cited in its field
- References
- 44 works
- Access
- Open access (hybrid journal) · CC-BY
- Research areas
- Phytochemicals and Medicinal Plants · Medicinal Plants and Neuroprotection · Andrographolide Research and Applications
- Keywords
- Placebo, Piperine, Medicine, Withania somnifera, Repeated measures design, Hamilton Anxiety Rating Scale, Anxiety, Randomized controlled trial, Internal medicine, Traditional medicine, Pharmacology, Psychiatry
- MeSH
- humans, withania, plant roots, serotonin, alkaloids, piperidines, plant extracts, phytotherapy, double-blind method, depression, anxiety, quality of life, adult, middle aged, female, male, benzodioxoles, polyunsaturated alkamides, young adult
6 authors
From US, IN
- Muhammed A. MajeedSabin Vaccine Institute
- Kalyanam NagabhushanamSabin Vaccine Institute
- Avinash Murali
- Devarajan T VishwanathanApollo Hospitals; Apollo Hospitals
- Ramamohan V MamidalaNarayana Dental College and Hospital
- Lakshmi Mundkur · corresponding
Abstract
Background: Withania somnifera (Linn) or Ashwagandha is used in Ayurveda and other traditional medicine systems as an adaptogen and a neuroprotective supplement. Objective: The effect of Ashwagandha root extract (ARE) standardized for 2.5% full-spectrum withanolides as per The United States Pharmacopeia (USP) protocol with piperine (500 mg with 5 mg of 95% piperine) once a day (12.5 mg withanolides/day) was evaluated in individuals with mild to moderate depression and anxiety. Methods: In a randomized, double-blind placebo-controlled study, for 90 days, 70 participants were randomized to ARE (n = 34) or placebo (n = 36) once daily at night. Mean change in the Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Rating Scale (HARS), Groningen Sleep Quality Scale (GSQS), and quality of life (QOL) from screening to days 30, 60, and 90 were evaluated. Safety was evaluated by monitoring any incidence of adverse events and laboratory parameters. Two-way analysis of variance (ANOVA) and repeated-measure ANOVA were used to compare ARE and placebo, and the changes within the group at different time points. Results: Seventy individuals were randomized and all of them completed the study. The HARS, HDRS, GSQS, and QOL scores improved significantly (p p Conclusion: The results of the study suggest that 500 mg of ARE standardized for 2.5% withanolides with 5 mg piperine is beneficial in improving depression, and anxiety, by increasing serum serotonin levels. The trial was registered prospectively with the Clinical Trial Registry of India (CTRI) with the registration number CTRI/2022/05/042640, on May 18, 2022.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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