An Ayurvedic formulation to manage the sleeplessness in old age populatio
Phase 2
Not yet recruiting
- Conditions
- Health Condition 1: G470- Insomnia
- Registration Number
- CTRI/2022/11/047028
- Lead Sponsor
- Dr Omkar Devidas Ingale
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Individuals above & equal to 60 years of age having insomnia of minimum 3 months
duration
2) Either sex
3) Insomnia Severity Index above score 7
Exclusion Criteria
1) Patients with k/c/o psychiatric illness like Schizophrenia, Major depressive disorder,
Psychosis, Epilepsy, Anxiety disorders, etc.,
2) Patients with k/c/o Alcohol Dependency or Drug dependency and Hypotension.
3) Patient with other k/c/o sleep disorders like Narcolepsy, Breathing-related Sleep Disorder,
Circadian Rhythm Sleep Disorder, Parasomnia, Hypersomnolence, etc.,
4) Patients with other k/c/o illness like Asthma, Malignancies, Liver Cirrhosis, Chronic Renal
Failure, etc.,
5) Use of Hypnotics by Prescription, Psychotherapy within the past 4 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Srapagandha Choorna Yoga capsule will be helpful in the improvement of quality and quantity of sleep and quality of life amongst geriatric population and hence better management of Anidra (Insomnia) through <br/ ><br>1)Insomnia Severity IndexTimepoint: 0th day 15th day and 30th day
- Secondary Outcome Measures
Name Time Method Srapagandha Choorna Yoga capsule will be helpful in the improvement of quality & quantity of sleep & quality of life amongst geriatric population & hence better management of Anidra (Insomnia) through <br/ ><br> <br/ ><br>1) Ayurvedic Assessment Parameters <br/ ><br>2) Pittsburgh Sleep Quality Index <br/ ><br>3) Epworth Sleepiness Scale-Pictorial <br/ ><br>4) Short Form 36 Health Survey Questionnaire (SF36) <br/ ><br>5) Depression Anxiety Stress sacle-21 <br/ ><br>6) Geriatric Sleep Questionnaire-6Timepoint: 1)Ayurvedic Assessment Parameters <br/ ><br>2)Pittsburgh Sleep Quality Index <br/ ><br>3)Epworth Sleepiness Scale-Pictorial <br/ ><br>4)Short Form 36 Health Survey Questionnaire (SF36) <br/ ><br>these four scales will be assessed on 0th & 30th day <br/ ><br> <br/ ><br>5)Depression Anxiety Stress sacle-21 <br/ ><br>6)Geriatric Sleep Questionnaire-6 <br/ ><br>these three parameters will be assessed for 0th day 15th day & 30th day