To Study the Effect of Plant Formulation on sleep in Patients with Depression.
Phase 3
- Conditions
- Health Condition 1: null- Depressive symptoms with cognitive impairment, Sleep Disturbances
- Registration Number
- CTRI/2016/02/006681
- Lead Sponsor
- Interdisciplinary Institute of Indian System of Medicine University Building Fourth Floor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Patients with age between 30 - 65 years (Both genders)
2. Patient health questionnaire (PHQ-9) scores 5-14
3. Hamilton depression rating scale score 19-22.
4.Patient must meet the DSM-V Criteria for Depression.
Patients willing to give informed consent.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep Efficiency, REM Sleep, Melatonin & Neopterin levelsTimepoint: visit 3, visit 6
- Secondary Outcome Measures
Name Time Method Improvement of Cognitive, Memory status, Neopterin levels.Timepoint: NA