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CTRI Number  CTRI/2025/06/089325 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 20/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Improving Quality of life in Depression with homeopathy. 
Scientific Title of Study   Effectiveness Of Individualized Homeopathic Medicines in Improving The Social Quality of Life And Satisfaction in Depression Among Working Population- A Quasi Experimental Study 
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 TANGUDU MANISHA 
Designation  Post Graduate Scholar, Department of Psychiatry, 
Affiliation  National Homoeopathic Research Institute in Mental Health 
Address  Post Graduate Scholar Department of Psychiatry Room no 8 National Homoeopathy Research Institute in Mental Health

Kottayam
KERALA
686532
India 
Phone  9951593565  
Fax    
Email  ammanannamanisha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M GNNANAPRAKASHAM  
Designation  Associate Professor, Department of Psychiatry 
Affiliation  National Homoeopathic Research Institute in Mental Health 
Address  Associate Professor Department of Psychiatry Room no 9 National Homoeopathy Research Institute in Mental Health

Kottayam
KERALA
686532
India 
Phone  9444701176  
Fax    
Email  drgprakashpsy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M GNNANAPRAKASHAM  
Designation  Associate Professor, Department of Psychiatry 
Affiliation  National Homoeopathic Research Institute in Mental Healt 
Address  Associate Professor Department of Psychiatry Room no 9 National Homoeopathic Research Institute in Mental Health

Kottayam
KERALA
686532
India 
Phone  9444701176  
Fax    
Email  drgprakashpsy@gmail.com  
 
Source of Monetary or Material Support  
National Homoeopathic Research Institute in Mental Health Kurichy,Sachivothamapuram PO Kottayam, Kerala 686532 India 
 
Primary Sponsor  
Name  Dr TANGUDU MANISHA  
Address  National Homoeopathic Research Institute in Mental Health,Sachivothamapuram p o, kurichy, kottayam, kerala-686532,India. 
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 TANGUDU MANISHA  National Homoeopathic Research Institute in Mental Health  Department of Psychiatry Post Graduate Room no 8
Kottayam
KERALA 		 9951593565

ammanannamanisha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee -National Homoeopathic 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: F30-F39||Mood [affective] disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised Homoeopathic Medicines   Each patient satisfying the inclusion criteria will be enorrlled.After enrollment the case will be repertorised.Appropriate potentized Individualised Homoeopathic Medicine will be administered in minimum dose in appropriate potency according to the need of the case. Medicine is administered orally. Repetition will be done when improvement comes to a standstill in a higher potency of the same medicine and if the medicine is not found to be effective the case will be retaken then another appropriate medicine is given. The above homoeopathic intervention will be given for a period of 6 months. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Cases satisfying icd 11 diagnostic criteria
Subjects of working population
Subjects of both the sexes
Score of Q-LES-Q(sf) greater than equal to 14
Score of PHQ9 greater than equal to 5 
 
ExclusionCriteria 
Details  1.Depressive patients with severe suicidal ideation.
2. Mood disturbances when associated with schizophrenia spectrum disorder, Depressive episode in
Bipolar affective disorder, other psychotic disorder.
3. Subjects who are pregnant or lactating.
4. Severe systemic illness.
5. Subjects who used psychotropic medicines in past 2weeks 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome will be measured by the difference between the score obtained in Q-LES-Q(sf)
questionnaire in the baseline and end of the treatment. 		 Baseline at 3rd,6th,9th month and at the conclusion of the study (12th month) 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome will be measured by the difference between the score obtained in Patients Health Questionnaire-9 scale
2.Copenhagen Burnout Inventory scale in the baseline and end of
the treatment.  		 1.Every month from baseline till the conclusion of the
study (12 months)
2.Baseline at 3rd,6th,9th month and at theconclusion of the study (12th month 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   02/07/2025 
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="8"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ammanannamanisha@gmail.com].

  6. For how long will this data be available start date provided 26-06-2025 and end date provided 11-11-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This quasi experimental study evaluates the effectiveness of individualized homoeopathic medicines in improving the social quality of life and satisfaction in depression among the working population using Quality of Life Enjoyment and Satisfaction questionnaire Q-LES-Q (sf).Secondary objective include to find out the overall improvement in Depression among working population using Patient Health Questionnaire-9 (PHQ-9) scale and the reduction of work related burnout using Copenhagen Burnout Inventory (CBI) scale.Patients will be recruited from the Outpatient Department (OPD), Inpatient Department (IPD), and Peripheral Centres of the National Homoeopathic Research Institute in Mental Health (NHRIMH), Kottayam, based on ICD-11 criteria. Enrolment requires psychiatric confirmation, and informed consent will be obtained in English and Malayalam. Subjects will be assessed at baseline by using Patient Health Questionnaire (PHQ -9), Copenhagen Burnout Inventory scale (CBI) to get severity of the condition. The quality of life of the subjects will be assessed with Q-LES-Q-(sf) questionnaire. A detailed case history and mental status examination will be recorded, and individualized homoeopathic remedies will be prescribed based on repertorization via RADAR OPUS software and Homoeopathic Materia Medica. Acute exacerbations will be managed accordingly. Patients missing follow-ups for 
three consecutive months will be considered dropouts and will receive standard OPD care but will be excluded from further study evaluation. The study aims to find out the effectiveness of Homoeopathic medicines in improving the social quality of life and satisfaction in Depression among working population.
 
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