Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
Conditions
Interventions
None listed
Sponsors
Dr Dileep K S
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed case of insomnia disorder according to DSM 5 criteria Age group between 20 and 60 years Patients of both genders, irrespective of socioeconomic status
Exclusion criteria
Exclusion criteria: Insomnia due to substance abuse or trauma Physiological conditions such as pregnancy lactation and puerperal stage Subjects with milk allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in insomnia severity after treatment with Pancharavinda Choornam, as assessed using Insomnia Severity IndexTimepoint: at baseline, 30 days & 45 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in overall sleep quality & sleep disturbances from baseline to the end of treatment, as assessed using the Pittsburgh Sleep Quality Index Timepoint: at baseline, 30 days & 45 days;Change in depression, anxiety, & stress scores from baseline to the end of treatment, as assessed using the Depression Anxiety Stress Scale Timepoint: at baseline, 30 days & 45 days;Safety & tolerability of Pancharavinda Choornam, as assessed by the incidence of adverse events & changes in liver function tests & serum creatinine from baseline to the end of treatmentTimepoint: at baseline, 30 days & 45 days | — |
Countries
India
Contacts
Public ContactDr Dileep K S
Vaidyaratnam
Outcome results
None listed