Efficacy and safety of Ashwagandha root extract sustained-release (AshwaSR) capsules in healthy adult, stressed subjects: A randomized, double-blind, placebo-controlled, parallel-group, 3-arm clinical trial
Thanawala S, Shah R, Alluri KV, Bhupathiraju K, Desomayanandanam P, Bhuvenendran A
Medicine · 1 cita
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2026-03-13 · Medicine (Baltimore) · vol. 105 · número 11 · pág. e47990
- Editorial
- Wolters Kluwer
- Citado
- 1 cita · más que el 95% de estudios similares · 9.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 24 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Phytochemicals and Medicinal Plants · Medicinal Plants and Bioactive Compounds · Medicinal Plant Extracts Effects
- Palabras clave
- ashwagandha root extract, Withania somnifera, adaptogens, perceived stress, stress reduction, sleep quality, psychological well-being, dietary habits, serum cortisol, sustained-release formulation, herbal supplement safety
- MeSH
- humans, withania, plant roots, hydrocortisone, plant extracts, capsules, delayed-action preparations, double-blind method, feeding behavior, stress, psychological, adult, middle aged, female, male, young adult, sleep quality, subjective stress
6 autores
- Shefali Thanawala · autor de correspondencia
- Rajat Shah
- Krishnaraju Venkata Alluri
- Kiran Bhupathiraju
- Prabakaran Desomayanandam
- Arun Bhuvanendran
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
The adaptogenic effects of Ashwagandha root extract are evident. An earlier study showed the therapeutic effects of a once-daily sustained-release (SR) formulation (300 mg) of Ashwagandha root extract over an extended period. This study aimed to evaluate the efficacy and safety of Ashwagandha root extract sustained-release (AshwaSR) 150 and 300 mg capsules in reducing stress in healthy adult, stressed subjects.
Methods
In this double-blind, randomized, placebo-controlled trial, healthy subjects with Perceived Stress Scale score 14 to 26 were randomized (1:1:1) to AshwaSR 150 mg (group A) or 300 mg (group B) or placebo (group C). Change from baseline to day 60 was evaluated for stress levels, sleep quality, psychological well-being, eating behavior, and serum cortisol levels in all groups.
Results
Of 135 subjects randomized, 126 completed the trial (mean age, 34.79 ± 8.16 years). Mean Perceived Stress Scale scores significantly reduced from baseline to day 60 in group A and B (mean change, 38.6% and 41.6% respectively; P < .001). Sleep quality, psychological well-being, and eating behavior significantly improved from baseline to day 60 in groups A and B (P < .001). Serum cortisol levels in group B were significantly reduced on day 60 (P < .05). Both group A and B showed significant improvements in stress levels, sleep quality, psychological well-being, and eating behavior at day 60 (P < .05) compared to group C. No safety concerns were reported.
Conclusion
AshwaSR 150 and 300 mg capsules reduced perceived stress and improved sleep quality, eating behavior, and psychological well-being and were safe in healthy adult, stressed subjects over 60 days of administration.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.