To study the effect of Ayurvedic treatments in Insomnia
- Conditions
- Health Condition 1: G470- Insomnia
- Registration Number
- CTRI/2023/07/054890
- Lead Sponsor
- DrAswini Ramachandran
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Individuals between the age group of 20 to 60 years having insomnia of minimum three month duration
2. Patients of Either sex.
3. Insomnia Severity Index >7
4. DASS-21 depression score <13, Anxiety score <9 and stress score <18
1. Patients with known cases of psychiatric illness like schizophrenia, Major depressive
disorder, Psychosis, Epilepsy, moderate to severe anxiety disorders.
2. Patients with Alcohol dependency or Drug dependency.
3. Patient with known cases of other sleep disorders like Narcolepsy, Breathing-related
sleep disorder, Circadian rhythm sleep disorder, or Parasomnia
4. Patients with other known cases of systemic illness like Thyroid, Asthma, Malignancies,
Liver disorders, Uncontrolled Hypertension, uncontrolled Diabetes mellitus & Chronic
renal failure.
5. Use of Hypnotics by prescription, Psychotherapy within the past 4 weeks.
6. Pregnant or lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Insomnia severity indexTimepoint: at baseline, 15th & 30th day
- Secondary Outcome Measures
Name Time Method Changes in Pittsburgh sleep quality index, from baseline & at 15th & 30th days. <br/ ><br>b. Changes in Epworth sleepiness scale from baseline and at 15th & 30th days. <br/ ><br>c. Changes in Manasabhava scale from baseline and at 15th & 30th days from baseline <br/ ><br>and at 15th & 30th days. <br/ ><br>d. Changes in Depression Anxiety and Stress Scale (DASS). <br/ ><br>Changes in Quality of life (SF36) from baseline and at 15th & 30th daysTimepoint: 0th day, 15th day, 30thday