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A clinical study on polyherbal Unani formulation in Depression.

A comparative study of Majoon Najah and Sharbat Ahmad Shahi in Depression-A randomized open label double arm clinical trial. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085978
Enrollment
40
Registered
2025-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F321- Major depressive disorder, singleepisode, moderate

Interventions

Intervention1: Majoon Najah: 10 gm at night for 2 months Control Intervention1: Sharbat Ahmad Shahi: 20ml twice a day for 2 months

Sponsors

Ayurvedic and Unani Tibbia College and Hospital
Lead Sponsor

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

MeasureTime 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

MeasureTime frame
Improvement in quality of life.Timepoint: Assessment of Quality of life Index at baseline and after 60th day.

Countries

India

Contacts

Public ContactSaheefa Atam

Ayurvedic and Unani Tibbia College and hospital

drnusrathfarooque@rediffmail.com9131807199

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026