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CTRI Number  CTRI/2023/12/060416 [Registered on: 01/12/2023] Trial Registered Prospectively
Last Modified On: 29/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to find out the effect of homoeopathic medicines in the management of Depression along with supportive counseling 
Scientific Title of Study   The efficacy of individualized homoeopathic medicines in the management of Major Depressive Disorder with supportive counseling- a double blind randomized placebo controlled 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  DR K MADHAVI PRIYANKA 
Designation  PG scholar- Department of Psychiatry 
Affiliation  National Homoeopathy Research Institute in Mental Health 
Address  PG scholar- Department of Psychiatry National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (p.o), Kurichy, Kottayam

Kottayam
KERALA
686532
India 
Phone  9747127538  
Fax    
Email  madhavipriyanka21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR R BHUVANESWARI 
Designation  Professor and Head of the Department, Research Officer(H), Scientist III, Department of Psychiatry 
Affiliation  National Homoeopathy Research Institute in Mental Health 
Address  Professor and Head of the Department, Research Officer(H), Scientist III, Department of Psychiatry National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (p.o), Kurichy, Kottayam

Kottayam
KERALA
686532
India 
Phone  8281475541  
Fax    
Email  dr.r.bhuvaneswari2021@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR R BHUVANESWARI 
Designation  Professor and Head of the Department, Research Officer(H), Scientist III, Department of Psychiatry 
Affiliation  National Homoeopathy Research Institute in Mental Health 
Address  Professor and Head of the Department, Research Officer(H), Scientist III, Department of Psychiatry National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (p.o), Kurichy, Kottayam

Kottayam
KERALA
686532
India 
Phone  8281475541  
Fax    
Email  dr.r.bhuvaneswari2021@gmail.com  
 
Source of Monetary or Material Support  
National Homeopathy Research Institute in Mental Health, Sachivothamapuram (p.o), Kurichy, Kottayam, Kerala 686532 India 
 
Primary Sponsor  
Name  Dr K Madhavi Priyanka 
Address  National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (P.O), Kurichy, Kottayam, Kerala 686532 
Type of Sponsor  Other [SELF] 
 
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 K Madhavi Priyanka  National Homoeopathy Research Institute in Mental Health   OPD, IPD, camps and Peripheral OPDs, Department of Psychiatry,National Homoeopathy Research Institute in Mental Health, Sachivothamapuram(P.O), Kurichy, Kottayam
Kottayam
KERALA 		 9747127538

madhavipriyanka21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ehical Committee - National Homeopathy Research Institute in Mental Health, Kottayam  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (2) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A- Individualized Homoeopathic medicines  Patients with major depressive disorder are divided into group A- individualized medicine group and group B- placebo group through randomization as per randomization chart after detailed case taking. This will be done by a third party to avoid bias. Individualized homoeopathic medicines (5 globules of 20 size) of centesimal potencies ranging from 6c to 10M will be given to the subjects of group A orally as per the requirement of the case according to the homoeopathic principles for a period of 6 months. Supportive counseling will be given by psychiatric social worker during the same period. The Hamilton Depression Rating Scale (HDRS) will be assessed every month after which the dose, potency and frequency of repetition will be changed as per the requirement of case.  
Comparator Agent  Group B -Placebo  For subjects allocated in the group B- placebo group after randomization done by third party, placebo will be administered in 5 globules of 20 size orally for 6months. The outcome measurement will be done by Hamilton Depression Rating Scale monthly as same as Group A- individualized homoeopathy medicine group. Supportive counseling will be administered by psychiatric social worker during the same period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age group between 18-60 yrs of both sexes
2. Patient presenting with symptoms of mild and moderate depressive disorder for at least
2 weeks duration and fulfilling the diagnostic criteria of DSM-V
3. Patients with Becks depression inventory score between 17-30 
 
ExclusionCriteria 
Details  1. Patients having suicidal ideation with a history of attempted suicide.
2. Patients with severe depressive disorders taking anti depressants and antipsychotics.
3. Any other psychiatric co morbidities
4. Alcohol abuse/any serious physical illness using conventional treatment.  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The Hamilton Depression Rating Scale (HDRS) will be assessed every month. The outcome measurement will be done by comparing the Hamilton Depression Rating Scale scores of subjects of both group A and group B at baseline, 3rd month and 6th month  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
The WHO QOL- BREF scale will be assessed at the baseline and 6th month of the study.  6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   11/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/12/2023 
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  

This study is conducted to  determine the efficacy of individualized homoeopathic medicines in managing major depressive disorder as compared to placebo. Mild and moderate cases of depressive disorder will be taken. The primary outcome is to assess the changes in major depressive disorder using Hamilton Depression Rating Scale and secondary outcome is to find out the changes in quality of life using WHO QOL BREF at the end of 6 months. This study is one of its kind in terms of design and sample size. Hence this can be considered as the need of the hour to make a convincing and reliable statement to validate the efficacy of homoeopathy in treating major depressive disorder.

 
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