A clinical study on polyherbal Unani formulation in Depression.

Phase 2

Not yet recruiting

Conditions: Major depressive disorder, singleepisode, moderate,

Registration Number: CTRI/2025/04/085978

Lead Sponsor: Ayurvedic and Unani Tibbia College and Hospital

Brief Summary: The study is Randomized, parallel group, open label,comparative clinical trial to evaluate the efficacy and safety of Majoon Najahand Sharbat Ahmed Shahi in the management of Depression. Depression is a commonillness characterized by persistent sadness and a loss of interest inactivities that one normally enjoys, accompanied by an inability to carry outdaily activities, for at least two weeks. It is a serious mental health concernthat impacts a person’s ability to work, their relationships, and significantlydestroys their quality of life. It is believed that severe depression can havedevastating consequences including suicidal ideation and attempts. About 3.8percent of the population suffers from depression, including 5 percent ofadults. Approximately 280 million people in the world have depression. Womenare 50 percent more likely to experience depression when compared to men with aprevalence rate of 6 percent among women and 4 percent in men. The NationalMental Health Survey 2015 in India reports that 1 in 20 individuals aged 18 orolder have suffered from depression at least once in their lifetime. More than700 000 people die by suicide every year. The World Health Organizationestimates that depression accounts for 4.3 percent of the global disease burdenand projects that it will become the leading contributor by 2030. In modernmedicine, first-line course of antidepressant treatment is insufficient toachieve remission in 68 percent of cases. The current antidepressants used havelimitations in both efficacy and tolerability. The scientists are increasinglyfocusing on exploring and developing new antidepressant drugs derived fromplants and their active compounds. Unani medicine is known for being safe,effective, readily accessible, cost effective and with least side effects.Certain plants have been utilized in the Unani system of medicine for treatingpsychiatric ailments including depression. The purpose of the study is toevaluate the efficacy and safety of Majoon Najah and Sharbat Ahmed Shahi in themanagement of Depression on modern scientific parameters.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

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

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.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To evaluate safety and efficacy of proposed Unani formulations.	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.
2.To compare the results of two unani compound formulations in the management of Depression in respect to safety and efficacy.	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 Outcome Measures

Name	Time	Method
Improvement in quality of life.	Assessment of Quality of life Index at baseline and after 60th day.

Trial Locations

Locations (1): Ayurvedic and Unani Tibbia College and Hospital
🇮🇳
Central, DELHI, India
Ayurvedic and Unani Tibbia College and Hospital
🇮🇳Central, DELHI, India
Dr Saheefa Atam
Principal investigator
8010336045
saheefaatam98@gmail.com