A clinical trial to study the effect of takra bhavita bilwa patra choorna in patients with anidra (primary insomnia)
Phase 2
Completed
- Conditions
- Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
- Registration Number
- CTRI/2022/07/044242
- Lead Sponsor
- Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Subjects fulfilling at least one diagnostic criteria and with Insomnia severity index above 8.
Patients of all gender, irrespective of socio-economic status.
Patients ready to sign informed consent form.
Exclusion Criteria
Known case of substance abuse.
Previously diagnosed psychiatric cases under medication with psychotropic effects or properties known to affect sleep-wake cycle.
Known cases of severe or unstable, acute or chronically progressive medical or surgical disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The quantity and quality of sleep will be assessed by adopting Insomnia Severity Index scale on the 0 day, 30th Day of the treatment And on the day of Follow Up <br/ ><br>Timepoint: The quantity and quality of sleep will be assessed by adopting Insomnia Severity <br/ ><br>Index scale on the 0 day, 30th Day of the treatment And on the day of Follow Up <br/ ><br>
- Secondary Outcome Measures
Name Time Method The quantity and quality of sleep will be assessed by adopting Insomnia Severity <br/ ><br> Index scale on the 0 day, 30th Day of the treatment And on the day of Follow Up <br/ ><br>Timepoint: 1 year