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 citas
Cómo se estudió
- Diseño
- Ensayo clínico controlado (clasificado por nuestro filtro de IA)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
Según la declaración de financiación del texto completo.
Publicación
- Publicado
- 2023-12-27 · J Ayurveda Integr Med · vol. 15 · número 1 · pág. 100859
- Editorial
- Elsevier BV
- Citado
- 32 citas · más que el 99% de estudios similares · 10.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 49 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY-NC-ND
- Áreas de investigación
- Phytochemicals and Medicinal Plants · Pharmacology and Nanomedicine Research · Andrographolide Research and Applications
- Palabras clave
- Withania somnifera, Tolerability, Medicine, Adverse effect, Clinical trial, Traditional medicine, Internal medicine, Pathology, Alternative medicine
6 autores
- V. G. Vaidya🇮🇳K. J. Somaiya Hospital & Research Centre
- Amol Gothwad🇮🇳K. J. Somaiya Hospital & Research Centre
- Gayatri Pramod Ganu
- Aboli Girme🇮🇳Directorate of Medicinal and Aromatic Plants Research
- Siddharth J. Modi🇮🇳Directorate of Medicinal and Aromatic Plants Research
- Lal Hingorani · autor de correspondencia
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).
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