Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
Conditions
Interventions
None listed
Sponsors
Dr Nikita Gajanan Deulkar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 60 years 2. Diagnosed cases of Primary Insomnia based on Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-IV) 3. AIS score more than or equal to 6 at baseline. 4. Duration of insomnia more than or equal to 1 month 5. Willingness to participate and provide written informed consent
Exclusion criteria
Exclusion criteria: Secondary insomnia due to psychiatric disorders (e.g., depression, anxiety) or medical conditions. History of substance abuse or sedative use within the past 2 weeks. Severe hepatic, renal, or cardiovascular illness. Pregnant or lactating women. Known allergy to trial drugs or their components. Known case of Lactose Intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study may provide improvement in sleep quality assessed by the Athens Insomnia Scale (AIS) score from baseline to after 30 days of treatment.Timepoint: At the end of 30 days (7th, 15th, 30th days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in severity of associated symptoms (Angamarda, Shirogaurava, Glani, and Jrumbha) before and after 30 days of treatment.Timepoint: At the end of 30 days (7th, 15th, 30th days) | — |
Countries
India
Contacts
Public ContactDr Nikita Gajanan Deulkar
Shri Ayurved Mahavidyalaya, Nagpur
Outcome results
None listed