A study to evaluate the efficacy of Aparajita Churna in Primary Insomnia.
Not Applicable
- Conditions
- Health Condition 1: G470- Insomnia
- Registration Number
- CTRI/2023/05/052263
- Lead Sponsor
- Dr. Stebin Anto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Subjects between age group of 21-60 years of either gender.
Subjects fulfilling the diagnostic criteria of Primary Insomnia according to DSM 5.
Mild and moderate cases as per Insomnia severity index (score between 8-21)
Subjects willing to participate with written informed consent, which is conveyed
in the language which the subject can understand
Exclusion Criteria
Subjects on sleep inducing medications.
Subjects on drugs known to cause drowsiness.
Subjects on psychiatric treatments.
Subjects with insomnia secondary to pre-existing conditions like Schizophrenia,
mood disorders, BPAD, etc.
Pregnant and Lactating women.
Any other condition interfering the course of the disease and the intervention.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Insomnia Severity IndexTimepoint: before intervention- 0th day <br/ ><br>during intervention- 15th day <br/ ><br>after intervention- 30th day <br/ ><br>follow up- 45th day
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI