None listed
Conditions
Interventions
None listed
Sponsors
International Institute of Seep Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1.Comparison of Change in NRS scores 2.Adverse effects 3. Changes in other Sleep parameters such as Total Sleep time, Sleep Efficiency, Microarousal index, REM latency. 4.Changes in PSQI scores 5.Change in HADS scores Timepoint: Visit 4, Visit 5 and Visit 6 | — |
Countries
India
Contacts
Public ContactDr Abhijit Deshpande MD
International Institute of Sleep Sciences
Outcome results
None listed