To study the effect of Ashwagnadha by polysomnogram on non-restorative sleep
- Registration Number
- CTRI/2021/11/038157
- Lead Sponsor
- International Institute of Seep Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
The following criteria are to be checked at the time of screening. The subject may only be included in the study if ALL the following statements are FULLFILLED:
1.With age of at least 18 years to 65 years
2.RSQ-W total score ï?£ 50
3.Have not taken any hypnotic medicines, Supplements or Ashwagandha within last 3 months
4.Able to communicate and read in English
5.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
6.Covid vaccinated for at least 4 weeks
7.No Caffeine or Alcohol intake 12 hours prior to Polysomnogram study
8.Willing to provide written informed consent
Those having heart disease, severe sleep apnea, severe plmd, severe anxiety and depression, pregnant women.History of alcohol and drug abuse. participants who were in other clinical trial for last 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean percent change in CAP rate Between Baseline and End of Treatment duration of 8 weeks. Comparison will be made between treatment arms.Timepoint: Visit 4, Visit 5 and Visit 6
- Secondary Outcome Measures
Name Time Method 1.Comparison of Change in NRS scores <br/ ><br>2.Adverse effects <br/ ><br>3. Changes in other Sleep parameters such as Total Sleep time, Sleep Efficiency, Microarousal index, REM latency. <br/ ><br>4.Changes in PSQI scores <br/ ><br>5.Change in HADS scores <br/ ><br>Timepoint: Visit 4, Visit 5 and Visit 6