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CTRI Number  CTRI/2025/04/084316 [Registered on: 07/04/2025] Trial Registered Prospectively
Last Modified On: 01/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Two modes of Treatments for Depression Classical Homeopathy vs Bach Flower Therapy  
Scientific Title of Study   An Open Lable Comparative Clinical Study On The Effectiveness Of Homoeopathic Medicine Through Homoeopathic Medical Repertory Vis-à-vis Bach Flower Remedies In Cases Of Major Depressive Disorder 
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 Harshnaben Sirishkumar Goti 
Designation  Ph.D Scholar, Assistant Professor 
Affiliation  Vidhyadeep Homoeopathic Medical College And Research Center Vidhyadeep University. 
Address  Room No.04 Homoeopahty Department Vidhyadeep Homoeopathic Medical College And Research Center Vidhyadeep University
Anita,Kim,Olpad
Surat
GUJARAT
394110
India 
Phone  09033860104  
Fax    
Email  dr.harshna.goti@vidhyadeepuni.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harshnaben Sirishkumar Goti 
Designation  Ph.D Scholar, Assistant Professor 
Affiliation  Vidhyadeep Homoeopathic Medical College And Research Center Vidhyadeep University. 
Address  Room No.04 Homoeopahty Department Vidhyadeep Homoeopathic Medical College And Research Center Vidhyadeep University
Anita,Kim,Olpad
Surat
GUJARAT
394110
India 
Phone  09033860104  
Fax    
Email  dr.harshna.goti@vidhyadeepuni.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vipul R Shastri 
Designation  Principal Of VHMC and RC,I/C Provost of Vidhyadeep University, Guide 
Affiliation  Vidhyadeep Homoeopathic Medical College And Research Center Vidhyadeep University 
Address  Room No.04 Homoeopahty Department Vidhyadeep Homoeopathic Medical College And Research Center Vidhyadeep University
Anita,Kim,Olpad
Surat
GUJARAT
394110
India 
Phone  9824109174  
Fax    
Email  drvipulshastri@gmail.com  
 
Source of Monetary or Material Support  
Room no 4 Homoeopathy Department vidhyadeep Homoeopathic Medical College and Research Centre Vidhyadeep University Anita kim surat Gujarat 394110 India  
 
Primary Sponsor  
Name  Vidhyadeep Homoeopathic Medical College And Research Center Anita Kim 
Address  Vidhyadeep University,Anita,Kim,Surat,394110 
Type of Sponsor  Other [This is Homoeopathic Medical College And Research Center Along With Hospital] 
 
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 Harshnaben Sirishkumar Goti  Vidhyadeep Homoeopathic Medical College And Research Centre  Room No.04, Homoeopathy Department Vidhyadeep University Anita Kim
Surat
GUJARAT 
09033860104

dr.harshna.goti@vidhyadeepuni.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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  Bach Flower Remedy   Patients will take 1-4 drops of Bach Flower Remedy in 1 cup(15-30 ml) of water. Treatment will last for 6 months, with 15 days of follow-ups 
Comparator Agent  homoeopathic medicine using repertory tool homoeopathic medical repertory  Patients will receive individualized homeopathic medicines chosen using a homeopathic repertory tool. Treatment will last for 6 months, with 15 days of follow-ups 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Cases irrespective of gender, education, occupation, ethnicity
2) Both sexes of 18 to 80 years of age group
3) Cases which are diagnosed as depression as per DSM-5 diagnostic criteria and scored based on HAM-D scale
4) Cases with systemic pathology will be included in this study
5) Cases with previous drug history of psychiatric drug will be included in this study  
 
ExclusionCriteria 
Details  1) Cases with irregular follow ups
2) Cases which do not full fill the diagnostic criteria of DSM-5 and HAM-D scale
3) Pediatric cases, gestational as well as lactational women will be excluded
4) Cases with past history of suicide attempts or threat
5) Cases with substance abuse (Chronic alcoholism, drugs, chain smokers, etc.)
6) Cases with critical condition with poor prognosis will be excluded from the study
7) Those individual who are unwilling to provide written consent for participation in this research study will be Excluded
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in severity of depressive symptoms as assessed by Hamilton Depression Rating Scale (HAM-D)  Measured at baseline and at the end of the 6 months treatment period. 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in psychological symptoms indicators (assessed using validated questionnaires or scale)at baseline and the end of the 6-month treatment  Measured at baseline and at the end of the 6-months treatment period. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/04/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 an open-label, randomized clinical trial designed to compare the effectiveness of two different homeopathic treatments for Major Depressive Disorder (MDD). It aims to evaluate traditional repertory-based homeopathic medicine versus Bach Flower Remedies over a treatment period of six months. The research follows a parallel group, active-controlled design and will be conducted over three years, involving 100 participants.Participants will be randomly assigned to one of two groups. The experimental group will receive Bach Flower Remedies, taken as 1-4 drops in a cup of water, while the control group will be treated with traditional homeopathic medicines, prescribed based on individual case analysis using a homeopathic repertory. Both groups will undergo case management for six months, with follow-ups based on individual needs.The study’s primary goal is to measure the reduction in depressive symptoms using the Hamilton Depression Rating Scale (HAM-D). A secondary objective is to assess improvements in the psychological dimension of health.


The study is open to men and women aged 18 to 80 years, diagnosed with depression according to the DSM-5 diagnostic criteria, and assessed using the HAM-D scale. Participants with systemic diseases or a history of psychiatric medication use can also be included. However, individuals who fail to follow up regularly, do not meet the DSM-5 and HAM-D criteria, or have a history of suicidal attempts, substance abuse, or critical illness with poor prognosis will be excluded. Pediatric cases, pregnant and breastfeeding women, and individuals unwilling to provide written consent will also not be included.The significance of this study lies in its potential to offer scientific evidence on the effectiveness of homeopathic treatments for depression. By comparing these two approaches, the research may help identify alternative treatment options for managing Major Depressive Disorder, benefiting both patients and healthcare practitioners.


 
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