Financiado en parte por Arjuna Natural Private Ltd., Kerala
A randomized, double blind, placebo controlled study to evaluate the effects of ashwagandha (Withania somnifera) extract on sleep quality in healthy adults
Deshpande A, Irani N, Balkrishnan R, Benny IR
Sleep medicine · 48 citas
Etiquetas de revisión
Financiado por la industriaDatos 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
- Financiado por la industria
- Empresa
- Arjuna Natural Private Ltd., Kerala
Según 1 financiador declarado.
Publicación
- Publicado
- 2020-03-21 · Sleep Med · vol. 72 · págs. 28–36
- Editorial
- Elsevier BV
- Citado
- 77 citas · más que el 98% de estudios similares · 7.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 47 trabajos
- Acceso
- De pago
- Áreas de investigación
- Phytochemicals and Medicinal Plants · Sleep and related disorders · Medicinal Plant Extracts Effects
- Palabras clave
- Withania somnifera, non-restorative sleep, sleep quality, herbal supplementation, sleep efficiency, sleep latency, wake after sleep onset, total sleep time, quality of life, actigraphy
- MeSH
- humans, withania, plant extracts, double-blind method, sleep, quality of life, adult, india
4 autores
- Abhijit Deshpande · autor de correspondencia
- Nushafreen Irani
- Ratna Balkrishnan
- Irin Rosanna Benny🇮🇳Amala Institute of Medical Sciences
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
Non-restorative sleep (NRS) affects 10% people worldwide, leading to poor sleep quality, as well as physical and cognitive fatigue. This is the first human study in which an extract of ashwagandha (Withania somnifera Dunal L.) was evaluated for effects in improving overall sleep quality in subjects with NRS.
Methods
In this randomized, double-blind, placebo-controlled trial, 150 healthy subjects scoring high on non-restorative sleep measures were given 120 mg of standardized ashwagandha extract (Shoden®) once daily for six weeks. Subjects were evaluated using the Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale. Sleep actigraphy was used to measure the onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset. Safety of the treatment was determined by testing of vitals, hematology, biochemistry and urinalysis.
Results
A total of 144 subjects completed the study, with no dropouts due to adverse events. A 72% increase in self-reported sleep quality was found for the treatment group, compared with 29% in the placebo group (p < 0.001). Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks. In the ashwagandha group quality of life (QOL) scores showed significant improvement in physical (p < 0.001), psychological (p < 0.001), and environment domains (p < 0.01).
Conclusions
Supplementation with the standardized ashwagandha extract for six weeks improved the overall quality of sleep by significantly improving the NRS condition in healthy subjects. No treatment related adverse events were reported in the study.
Trial registration
Clinical Trials Registry-India (www.ctri.nic.in). Registration number: CTRI/2017/02/007801.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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