Safety of Ashwagandha Root Extract: A Randomized, Placebo-Controlled, study in Healthy Volunteers
Verma N, Gupta SK, Tiwari S, Mishra AK
Complementary therapies in medicine · 55 citas
Etiquetas de revisión
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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
- 2020-12-16 · Complement Ther Med · vol. 57 · pág. 102642
- Editorial
- Elsevier BV
- Citado
- 108 citas · más que el 98% de estudios similares · 7.9× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 38 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Phytochemicals and Medicinal Plants · Pharmacology and Nanomedicine Research · Medical Case Reports and Studies
- Palabras clave
- Medicine, Placebo, Withania somnifera, Tolerability, Adverse effect, Vital signs, Traditional medicine, Randomized controlled trial, Internal medicine, Surgery, Alternative medicine
- MeSH
- humans, withania, plant extracts, medicine, ayurvedic, adult, healthy volunteers
4 autores
- Narsing Verma🇮🇳King George's Medical University
- Sandeep Kumar Gupta🇮🇳M.V. Hospital and Research Centre
- Shashank Tiwari🇮🇳M.V. Hospital and Research Centre
- Ashok Kumar Mishra🇮🇳 · autor de correspondenciaM.V. Hospital and Research Centre
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Ashwagandha (Withania somnifera) is a well-established and reputed herb in Ayurvedic medicine. It has been used as a "Rasayana" (rejuvenator), nootropic, and as a powerful natural adaptogen. The herb extract is extensively used for general wellbeing and in specific ailments. However, only a few studies have investigated the safety and tolerability of Ashwagandha in humans. This study evaluated the safety of Ashwagandha root extract consumption in healthy adults.
Methods
In this randomized, double-blind, placebo-controlled, and parallel-group study, 80 healthy participants (40 males, 40 females) were randomized in a 1:1 ratio to receive either Ashwagandha 300 mg or a placebo of the same dosage, twice daily, orally for 8 weeks. The study was conducted at MV Hospital, and King George Medical University, Lucknow, India. The primary safety outcomes considered were laboratory assessment of hematological parameters, serum biochemistry analysis including hepatotoxicity evaluation, and thyroid function parameters. The secondary outcomes of this study were the clinical adverse events and the vital parameters. The within and between the groups' datasets were compared using the Wilcoxon signed-rank test and the Mann Whitney U test, respectively.
Results
A detailed evaluation of the vital signs such as body weight, body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure, and Body Mass Index (BMI) were conducted for each participant at the baseline and the end of the study for treatment and placebo groups. Similarly, hematological and biochemical parameters were evaluated at the baseline and at the end of study. The outcome did not indicate any untoward effects in any of the treated volunteers. No statistically significant change or abnormality was observed in the considered parameters including thyroid hormonal profile in both the groups. No adverse events were reported by any of the participants in this study.
Conclusions
Ashwagandha is being consumed since time immemorial following the Ayurvedic medicine practices. Modern science requires evidence of the safety and efficacy of the Ashwagandha extract before mass consumption for various health issues and as a supplement. The present study revealed that the consumption of Ashwagandha root extract for 8 weeks was safe in both males and females volunteers. However, long term study and varying dosage ranges should be investigated in the future.
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