Clinical safety and tolerability evaluation of Withania somnifera (L.) Dunal (Ashwagandha) root extract in healthy human volunteers
Vaidya VG, Gothwad A, Ganu G, Girme A, Modi SJ, Hingorani L
Journal of Ayurveda and integrative medicine · 20 citations
How it was studied
- Design
- Controlled clinical trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
Based on full-text disclosure statement.
Publication
- Published
- 2023-12-27 · J Ayurveda Integr Med · vol. 15 · issue 1 · p. 100859
- Publisher
- Elsevier BV
- Cited
- 32 citations · more than 99% of similar papers · 10.0× the field average
- Impact
- Top 10% most cited in its field
- References
- 49 works
- Access
- Open access (journal) · CC-BY-NC-ND
- Research areas
- Phytochemicals and Medicinal Plants · Pharmacology and Nanomedicine Research · Andrographolide Research and Applications
- Keywords
- Withania somnifera, Tolerability, Medicine, Adverse effect, Clinical trial, Traditional medicine, Internal medicine, Pathology, Alternative medicine
6 authors
From IN
- V. G. VaidyaK. J. Somaiya Hospital & Research Centre
- Amol GothwadK. J. Somaiya Hospital & Research Centre
- Gayatri Pramod Ganu
- Aboli GirmeDirectorate of Medicinal and Aromatic Plants Research
- Siddharth J. ModiDirectorate of Medicinal and Aromatic Plants Research
- Lal Hingorani · corresponding
Abstract
Background
Withania somnifera (L.) Dunal, known as Ashwagandha, is an adaptogen with significant importance in Ayurveda for its potential health benefits in strength ('balavardhan') and muscle growth ('mamsavardhan'). Despite numerous studies on its efficacy, limited research is reported on its clinical safety and tolerability in healthy individuals.
Objective
This research evaluated the tolerability and safety of standardized Withania somnifera root extract (WSE) capsules (AgeVel®/Witholytin®) at 1000 mg/day dose upon oral administration in healthy male participants.
Method
A non-randomized, open-label, single-treatment clinical study included eighteen healthy male participants aged 18 to 60. The participants were administered a dose of 500 mg of the WSE capsules twice daily for four weeks. Each capsule contained not less than 7.50 mg of total withanolides. The study evaluated various indicators in a cohort of healthy participants throughout the trial, including vital signs, organ function tests, urine analysis, X-ray and ECG, cardiorespiratory endurance, body fat percentage, lean body weight, adverse events profile, and tolerability of the WSE capsules.
Results
The participant's physical, hematological, and biochemical characteristics were normal, and no significant alterations or irregularities were observed in safety metrics like liver, kidney, and thyroid functions after administering AgeVel®/Witholytin®.
Conclusion
This study found that healthy male participants could consume a standardized WSE at a daily dosage of 1000 mg for four weeks without any adverse effects. Future research should focus on long-term safety assessments in male and female participants.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).
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