| 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
|
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Scientific Title of Study
|
An Open Lable Comparative Clinical Study On The Effectiveness Of Homoeopathic Medicine Through Homoeopathic Medical Repertory Vis-Ã -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 |
|
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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 |
|
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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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. |
|
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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
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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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