CTRI Number |
CTRI/2025/04/085978 [Registered on: 29/04/2025] Trial Registered Prospectively |
Last Modified On: |
26/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Unani |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical study on polyherbal Unani formulation in Depression. |
Scientific Title of Study
|
A comparative study of Majoon Najah and Sharbat Ahmad Shahi in Depression-A randomized open label double arm clinical trial. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Saheefa Atam |
Designation |
MD Scholar Unani |
Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
Address |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi, India.
Central DELHI 110005 India |
Phone |
8010336045 |
Fax |
|
Email |
saheefaatam98@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Nusrath Fathima |
Designation |
Assistant professer |
Affiliation |
Ayurvedic and Unani Tibbia College and hospital |
Address |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi
Central DELHI 110005 India |
Phone |
9131807199 |
Fax |
|
Email |
drnusrathfarooque@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Saheefa Atam |
Designation |
MD Scholar Unani |
Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
Address |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi, India
Central DELHI 110005 India |
Phone |
8010336045 |
Fax |
|
Email |
saheefaatam98@gmail.com |
|
Source of Monetary or Material Support
|
Ayurvedic and Unani Tibbia College And Hospital, Karol Bagh, New Delhi-110005 |
|
Primary Sponsor
|
Name |
Ayurvedic and Unani Tibbia College and Hospital |
Address |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi, India- 110005 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Saheefa Atam |
Ayurvedic and Unani Tibbia College and Hospital |
Department of Moalajat Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi Central DELHI |
8010336045
saheefaatam98@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ayurvedic and Unani Tibbia College andHospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Majoon Najah |
10 gm at night for 2 months |
Comparator Agent |
Sharbat Ahmad Shahi |
20ml twice a day for 2 months |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
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. |
|
ExclusionCriteria |
Details |
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.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
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. |
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
|
Outcome |
TimePoints |
Improvement in quality of life. |
Assessment of Quality of life Index at baseline and after 60th day. |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
15/05/2025 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The study is Randomized, parallel group, open label,
comparative clinical trial to evaluate the efficacy and safety of Majoon Najah
and Sharbat Ahmed Shahi in the management of Depression. Depression is a common
illness characterized by persistent sadness and a loss of interest in
activities that one normally enjoys, accompanied by an inability to carry out
daily activities, for at least two weeks. It is a serious mental health concern
that impacts a person’s ability to work, their relationships, and significantly
destroys their quality of life. It is believed that severe depression can have
devastating consequences including suicidal ideation and attempts. About 3.8
percent of the population suffers from depression, including 5 percent of
adults. Approximately 280 million people in the world have depression. Women
are 50 percent more likely to experience depression when compared to men with a
prevalence rate of 6 percent among women and 4 percent in men. The National
Mental Health Survey 2015 in India reports that 1 in 20 individuals aged 18 or
older have suffered from depression at least once in their lifetime. More than
700 000 people die by suicide every year. The World Health Organization
estimates that depression accounts for 4.3 percent of the global disease burden
and projects that it will become the leading contributor by 2030. In modern
medicine, first-line course of antidepressant treatment is insufficient to
achieve remission in 68 percent of cases. The current antidepressants used have
limitations in both efficacy and tolerability. The scientists are increasingly
focusing on exploring and developing new antidepressant drugs derived from
plants 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 treating
psychiatric ailments including depression. The purpose of the study is to
evaluate the efficacy and safety of Majoon Najah and Sharbat Ahmed Shahi in the
management of Depression on modern scientific parameters. |