Study protocol and rationale for a prospective, randomized, double-blind, placebo-controlled study to evaluate the effects of Ashwagandha (Withania somnifera) extract on nonrestorative sleep
Deshpande A, Irani N, Balakrishnan R
Medicine · 7 citas
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
- Estudio de cohortes (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2018-06-01 · Medicine (Baltimore) · vol. 97 · número 26 · pág. e11299
- Editorial
- Wolters Kluwer
- Citado
- 17 citas · más que el 89% de estudios similares · 2.8× el promedio de su campo
- Referencias
- 19 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Phytochemicals and Medicinal Plants · Sleep and related disorders · Mindfulness and Compassion Interventions
- Palabras clave
- Medicine, Placebo, Actigraphy, Insomnia, Fibromyalgia, Physical therapy, Population, Polysomnography, Withania somnifera, Anxiety, Randomized controlled trial, Placebo-controlled study, Randomization, Internal medicine, Psychiatry, Double blind
- MeSH
- humans, c-reactive protein, plant extracts, polysomnography, prospective studies, double-blind method, research design, quality of life, adolescent, adult, aged, middle aged, female, male, randomized controlled trials as topic, young adult, sleep wake disorders
3 autores
- Abhijit P. Deshpande · autor de correspondencia
- Nushafreen Irani
- Rathna Balakrishnan
Resumen
El texto original del estudio, en el idioma en que se publicó.
Nonrestorative sleep (NRS) is one of the cardinal symptoms of insomnia and can occur independent of other components of insomnia. Among the sleep disturbances, NRS has been little studied in the general population, even though this symptom plays an important role in several medical conditions associated with chronic inflammation such as heart disease, fibromyalgia, and chronic fatigue syndrome, as well as various sleep disorders. There is paucity in the literature about effective treatments for NRS. Ashwagandha (Withania somnifera) has been demonstrated to reduce anxiety and stress, allowing the body to settle down and prepare for sleep. This study will be a double-blind, randomized, placebo-controlled interventional study in NRS population.The NRS participants are identified using Restorative Sleep Questionnaire-weekly version (RSQ-W) questionnaire. Actigraphy and polysomnography are used for the objective assessment of sleep. The other assessments used are Hamilton Anxiety Depression Scale (HADS), World Health Organization Quality of Life (WHOQOL) scales, and C-reactive protein. Routine blood and urine analyses will be conducted to assess the safety of treatment. Duration of study for each participant will be 50 days with "day one" for screening followed by randomization for the treatment. The duration for medicine/placebo intake shall be 42 days.Primary outcome will be to evaluate effect of daily supplement of ashwagandha extract compared with placebo in subjects with NRS at 6 weeks from baseline, as assessed by the total score of RSQ-W.
Ctri registration number
CTRI/2017/02/007801.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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