Health Condition 1: F30-F39- Mood [affective] disorders
Conditions
Interventions
None listed
Sponsors
Ministry of AYUSH, Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients more than 18 years of age. 2. Diagnosed of unipolar/bipolar depression as per screening Mini International Neuropsychiatric Interview (MINI). 3. Patients suitable for Virechana. 4. Ready to sign the informed consent form. 5. Right-handed subjects tested with Edinburgh Handedness Questionnaire. 6. At least 8 years of formal education.
Exclusion criteria
Exclusion criteria: 1. Patients on nutraceutical mood remedies - Such as St. Johnâ??s Wort, fish oil, SAMe, or high-dose vitamins - within 2 months of screening, or plan to initiate use during study. 2. Patients on psychotherapy or plan to initiate during study. 3. Patients who are already on yoga/mind-body practices or plan to initiate such practices during the study. 4. Patients whose impaired cognition score 5. Patients diagnosed with substance use disorder within 3 months of screening MINI. 6. Patients diagnosed with bipolar disorder or other Axis I disorder comorbid with major depression per screening MINI. 7. Patients with major depression, score > 28 on screening BDI. 8. Patients with history of suicide attempts, suicidal ideation or psychosis. 9. Any neurological disorders such as any significant head injury. 10. Patients with neuro degenerative disorders. 11. Patients of substance use disorders. 12. Pregnant and lactating women. 13. Patients with uncontrolled Type 2 Diabetes mellitus 14. Patients on β-blockers, thiazide diuretics, corticosteroids, HRT. 15. Patients with Uncontrolled Blood pressure. 16. Patients with concurrent Hepatic Dysfunction 17. Patients with Renal Dysfunction Patients with severe Pulmonary Dysfunction 18. Patients with evidence of malignancy 19. Patients suffering from major systemic illness necessitating long-term drug treatment. 20. Patients who have completed participation in any other clinical trial during the past six (06) months. 21. Left-handedness 22. Education level is less than 8th grade.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Hamilton Depression Rating Scale (HDRS), MADRAS, and Vishadha rating scaleTimepoint: Baseline, after virechana, 45th and 90th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in functional Magnetic Resonance Imaging (fMRI) 2. Changes in Herat Rate Variability (HRV). 3. Changes in Neuro gut biomarkers 4. Changes in Telomere length Timepoint: Baseline, after virechana, 45th and 90th day | — |
Countries
India
Contacts
Public ContactDr Kishore Kumar R
National Institute of Mental Health and Neurosciences
Outcome results
None listed