Effect of Shirolepa in Primary Insomnia
Not Applicable
- Conditions
- Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
- Registration Number
- CTRI/2022/09/045226
- Lead Sponsor
- ochan Acharya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Diagnosed with primary insomnia as per research diagnostic criteria for primary insomnia
2. The insomnia severity index (ISI) score is more than eight points but less than 21 points
Exclusion Criteria
1. Indication of moderate/severe depressive or anxiety symptoms (score > 14 on
the depression scale, score > 10 on the anxiety scale and score > 19 on the
stress scale of DASS-21)
2.Undergoing treatment or had taken any treatment for insomnia in < 3 months
3. Pregnant or lactating women
4.Nocturnal shift-work (i.e., working between 12:00 am and 6:00 am)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insomnia Severity Index (ISI)Timepoint: Baseline (after participant enrollment) <br/ ><br> <br/ ><br>Endpoint (after 7 days of intervention)
- Secondary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index (PSQI), Actigraphy wristwatch sleep parameters, Sleep diary, Epworth Sleepiness Scale (ESS)Timepoint: Baseline (after participant enrollment) <br/ ><br> <br/ ><br>Endpoint (after 7 days of intervention)