A clinical trial to Evaluate the Effects of Ashwagandha (Withania somnifera) Extract on Non-Restorative Sleep
- Registration Number
- CTRI/2017/02/007801
- Lead Sponsor
- International Institute of Sleep Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
With age of at least 18 years to 65 years
RSQ-W total score less than or equal to 50
Have not taken any hypnotic medicine or Ashwagandha within last 1 year
Able to communicate and read in English
Women of child-bearing potential (refer to appendix for definition) willing to use an adequate method of contraception to avoid pregnancy throughout the study period
Willing to provide written informed consent
Medical history of Ischemic Heart Disease, Valvular Heart Disease, Pacemakers, respiratory disorders, seizure disorders
Suffering from severe intrinsic sleep related disorders such as severe sleep apnea (STOP BANG questionnaire score greater than 5), moderate to severe restless leg syndrome (RLS), Narcolepsy
Suffering from severe grade untreated depression (Score of 15 or more for Anxiety or Depression when measured with Hospital Anxiety and Depression Scale)
Women who are pregnant or nursing.
Women with a positive pregnancy test on enrollment or 48 hours prior to study intervention
If the subjects required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including anxiolytics, central nervous system active drugs, hypnotics, narcotic analgesics, anti-inflammatory agents, antidepressants, proton pump inhibitors, antacids, beta blockers, anticonvulsants, St Johns Wort, sedating H1 antihistamines, Kava-kava, systemic steroids, Ginkgo biloba, respiratory stimulants, over the counter
and prescriptions stimulants, decongestants, over-the-counter and prescription diet aids, antipsychotics, melatonin, drugs for oral alkalinization and all other drugs or supplements known to affect sleep orwake
History of drug addiction or drug abuse within the past 12 months
History of alcohol abuse (regularly consumes more than 2 alcoholic drinks per day) within the past 12 months
Patients with hepatic impairment (SGOT or SGPT levels greater than 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine greaterthan or equal to 2.0 mg/dl).
Patients with any other severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures.
Patients with known history of hypersensitivity to Ashwagandha or any product containing Ashwagandha extract
Patients with any other serious concurrent illness or malignancy.
Participation in another clinical trial in the past 12 months
Any other factor which the investigator feel that can affect the findings of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in total score of Restorative Sleep Questionnaire-weekly version (RSQ-W) <br/ ><br>Change in Actigraphy parameters(Average number of awakenings per hour of sleep, Average total sleep time in one week, Sleep efficiency) <br/ ><br>Change in the Nocturnal Polysomnogram parameters <br/ ><br>Change in Quality of life scores using WHOQOL-BREF scale <br/ ><br>Change in Depression and anxiety scores using Hospital Anxiety and Depression Scale <br/ ><br>Change in C-reactive protein levels <br/ ><br>Timepoint: Screening, Day 8, Day 36, Day 50.
- Secondary Outcome Measures
Name Time Method Change in Actigraphy parameters(Average number of awakenings per hour of sleep, Average total sleep time in one week, Sleep efficiency) <br/ ><br>Change in the Nocturnal Polysomnogram parameters <br/ ><br>Change in Quality of life scores using WHOQOL-BREF scale <br/ ><br>Change in Depression and anxiety scores using Hospital Anxiety and Depression Scale <br/ ><br>Change in C-reactive protein levels <br/ ><br>Timepoint: Screening, Day 1, Day 2, Day 8,Day 36,Day 43 and Day 50.