Health Condition 1: null- Children from both sexes of age â?¥ 13 years and 18 years diagnosed with depression as per DSM IV TR criteria
Conditions
Interventions
Intervention1: Homoeopathic medicines with Cognitive Behaviour Therapy: Homoeopathic medicines in centisimal potencies to be administered during the treatment period as per the Randomisation list afte
Sponsors
Department of AYUSH Ministry of Health and Family Welfare Govt of India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children from both sexes of age >= 13 years and 2. Children diagnosed as suffering from depression as per DSM IV TR will be selected.
Exclusion criteria
Exclusion criteria: 1. Depression associated with organic brain lesion, Hypothyroidism and Chronic illness like T.B., HIV/ AIDS will be excluded. 2. Secondary depression due to intake of other allopathic drugs. 3. Subjects whose Legally acceptable representative (Parents or guardians) who are not willing to give written voluntary informed consent for the study 4. Subjects who are unable to participate for the entire duration of the study or in the opinion of the investigator are likely to be non compliant with the obligations inherent in the trial participation. 5. Subjects undertaking antidepressants or any recent history of antidepressants within 30 days of participation into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy parameters: 3 point change in RHRSD score will indicate clinically significant change. At least 25% improvement in clinical assessment criteria. Safety parameters: Clinical deterioration shown by â?¥10 increase in RHRSD score or with suicidal risks will be; a. Switched over to standard Homoeopathy treatment. Or b. According to consulting psychiatrist, if required, the child will be shifted to the allopathic line of treatment. Or c. Hospitalized, if custodian care is required.Timepoint: Primary end points: â?¢ â?¢ We expect 8 % improvement in the (RHRSD) at the end of 9 months from base line score. â?¢ 16 % improvement in RHRSD scores will imply marked improvement in depression at the end of 9 months from base line score.. | — |
Secondary
| Measure | Time frame |
|---|---|
| Significant improvement of functioning and behaviour assessed with the Child Behaviour Checklist (CBCL) at 9 months.Timepoint: At the end of 9 months. | — |
Countries
India
Contacts
Public ContactDr Praful M Barvalia
M.B. Barvalia Foundation Spandan Holistic Institute
Outcome results
None listed