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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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