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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.
Medicine (Baltimore). 2018 Jun; 97(26):e11299.M

Abstract

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.

Authors+Show Affiliations

International Institute of Sleep Sciences, Thane, Maharashtra, India.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29953014

Citation

Deshpande, Abhijit, et al. "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." Medicine, vol. 97, no. 26, 2018, pp. e11299.
Deshpande A, Irani N, Balakrishnan R. 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. Medicine (Baltimore). 2018;97(26):e11299.
Deshpande, A., Irani, N., & Balakrishnan, R. (2018). 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. Medicine, 97(26), e11299. https://doi.org/10.1097/MD.0000000000011299
Deshpande A, Irani N, Balakrishnan R. 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. Medicine (Baltimore). 2018;97(26):e11299. PubMed PMID: 29953014.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Deshpande,Abhijit, AU - Irani,Nushafreen, AU - Balakrishnan,Rathna, PY - 2018/6/29/entrez PY - 2018/6/29/pubmed PY - 2018/7/17/medline SP - e11299 EP - e11299 JF - Medicine JO - Medicine (Baltimore) VL - 97 IS - 26 N2 - : 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. SN - 1536-5964 UR - https://www.unboundmedicine.com/medline/citation/29953014/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_ L2 - https://doi.org/10.1097/MD.0000000000011299 DB - PRIME DP - Unbound Medicine ER -