Health Condition 1: F321- Major depressive disorder, singleepisode, moderate
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Clinically diagnosed patients with Major Depressive Disorder. 2.Patients with the score of more than or equal to 8 to less than or equal to 18 on Hamilton Depression Scale. 3.Patients currently experiencing major depressive episode for more than or equal to 2 weeks. 4.Patient currently not receiving any antidepressant or has discontinued more than 2 weeks prior to enrollment. 5.Patient currently not on antidepressants or has discontinued 2 weeks prior to enrollment.
Exclusion criteria
Exclusion criteria: 1.Severe cases of major depressive disorder with Hamilton Depression score of more than 18. 2.Patients below 18 and above 60 years of age. 3.Pregnant and breastfeeding women. 4.History of epilepsy, some major neurological disorder, head trauma or cognitive impairment. 5.Patients with a history of bipolar depression, schizophrenia or other psychotic disorder. 6.Initiating or stopping any formal psychotherapy within 6 weeks before enrollment. 7.Patient taking any other antidepressant. 8.Substance abuse history of psychoactive agents. 9.Patients with suicidal ideation or behavior within past 3 months. 10.Patients with Diabetes Mellitus, Hypertension, cardiovascular disorders, renal insufficiency, any other major chronic disorder and patients with any terminal condition such as cancer, AIDS etc. 11.Patients who refuse written consent form for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate safety and efficacy of proposed Unani formulations. 2.To compare the results of two unani compound formulations in the management of Depression in respect to safety and efficacy.Timepoint: 1.To evaluate efficacy: Assessment of Hamilton Depression score on baseline, 15th, 30th, 45th,60th day. 2.To evaluate safety: Haemogram, LFT, KFT at baseline and 60th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in quality of life.Timepoint: Assessment of Quality of life Index at baseline and after 60th day. | — |
Countries
India
Contacts
Ayurvedic and Unani Tibbia College and hospital