| CTRI Number |
CTRI/2025/12/099754 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Role of Miasmatic Diagnosis in the Homoeopathic Management of Acid Reflux Disease (GERD) |
|
Scientific Title of Study
|
TO UNDERSTAND THE MIASMATIC BACKGROUND OF GASTRO OESOPHAGEAL REFLUX DISEASE (GERD) AND ITS HOMOEOPATHIC MANAGEMENT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DARSHANKUMAR JADAV |
| Designation |
PG SCHOLAR |
| Affiliation |
BARODA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO PG 02 DEPARTMENT OF ORGANON OF MEDICINE AND HOMOEOPATHIC PHILOSOPHY 2ND FLOOR BARODA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL NR SONARKUI OPP XAVIER INSTITUTE SINDHROT ROAD SEVASI VADODARA
Vadodara
GUJARAT
391101
India |
| Phone |
9106742342 |
| Fax |
|
| Email |
darshanjadav26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RANJIT SINGH BEDWAN |
| Designation |
PROFESSOR |
| Affiliation |
BARODA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO PG 02 DEPARTMENT OF ORGANON OF MEDICINE AND HOMOEOPATHIC PHILOSOPHY 2ND FLOOR BARODA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL NR SONARKUI OPP XAVIER INSTITUTE SINDHROT ROAD SEVASI VADODARA
Vadodara
GUJARAT
391101
India |
| Phone |
9825027298 |
| Fax |
|
| Email |
rsbedwan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RANJIT SINGH BEDWAN |
| Designation |
PROFESSOR |
| Affiliation |
BARODA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO PG 02 DEPARTMENT OF ORGANON OF MEDICINE AND HOMOEOPATHIC PHILOSOPHY 2ND FLOOR BARODA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL NR SONARKUI OPP XAVIER INSTITUTE SINDHROT ROAD SEVASI VADODARA
GUJARAT
391101
India |
| Phone |
9825027298 |
| Fax |
|
| Email |
rsbedwan@gmail.com |
|
|
Source of Monetary or Material Support
|
| BARODA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
DR DARSHAN JADAV |
| Address |
ROOM NO PG 02DEPARTMENT OF ORGANON OF MEDICINE AND HOMOEOPATHIC PHILOSOPHY 2ND FLOOR BARODA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL SONARKUI OPP XAVIER TECHNICAL INSTITIUTE SINDHROT ROAD SEVASI VADODARA |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR RANJIT SINGH BEDWAN |
BARODA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
ROOM NO PG 02 DEPARTMENT OF ORGANON OF MEDICINE AND HOMOEOPATHIC PHILOSOPHY 2ND FLOOR BARODA HOMOEOPATHIC MEDICAL COLLEGE-HOSPITAL NR SONARKUI OPP XAVIER TECHNICAL INSTITUTE SINDHROT ROAD SEVASI VADODARA 391101
Vadodara
GUJARAT |
9825027298
rsbedwan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHMCHIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K21||Gastro-esophageal reflux disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HOMOEOPATHIC ANTI-MIASMATIC MEDICINES ACCORDING TO EACH INDIVIDUAL CASE |
EACH INDIVIDUAL PATIENT WILL BE GIVEN HOMOEOPATHIC ANTI-MIASMATIC TREATMENT ACCORDING TO THEIR MIASMS. THE POTENCIES AND REPETITION WILL BE BASED ON THE SUSCEPTIBILITY OF THE PATIENTS. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ALL AGE GROUPS (CHILDREN, ADULTS, ELDERS) AND BOTH SEXES WITH CINICALLY PRE-DIAGNOSED CASES OF GASTRO OESOPHAGEAL REFLUX DISEASE (GERD).
2. CASES WITH FUNCTIONAL CHANGES OR WITH REVERSIBLE PATHOLOGY.
3. PATIENTS WHO HAVE WILLINGNESS TO PARTICIPATE. |
|
| ExclusionCriteria |
| Details |
1. THE CASES WITH ACUTE EMERGENCY, CONGENITAL ANOMALY, SEVERE SYSTEMIC ILLNESS AND SEVERE IRREVERCIBLE PATHOLOGICAL CHANGES.
2. THE CASES WHICH DID NOT MAINTAIN A REGULAR FOLLOW UP.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GERD Q SCORE SYSTEM |
AT BASELINE AND AT THE END OF THE TREATMENT AS PER REQUIREMENT OF THE CASE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2025 |
| 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 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
|
THE STUDY TITLED "MIASMATIC DIAGNOSIS OF GASTRO OESOPHAGEAL REFLUX DISEASE(GERD) AND IT’S HOMOEOPATHIC MANAGEMENT" A CLINICAL VERIFICATION STUDY DESIGNED TO SCIENTIFICALLY EXAMINED HOW EFFECTIVE THE MIASMATIC DIAGNOSIS IS IN TREATING CLINICALLY CONFIRMED CASES OF GASTRO OESOPHAGEAL REFLUX DISEASE (GERD) THEY ARE USUALLY TREATED WITH CONVENTIONAL THERAPIES BUT THESE TREATMENTS OFTEN GIVE TEMPORARY OR SYMPTOMATIC RELIEF. HOMOEOPATHY WITH IT’S HOLISTIC AND INDIVIDUALIZED, ANTI MIASMATIC TREATMENT OFFERS AN ALTERNATIVE OPTION. MIASMATIC DIAGNOSIS OF GERD WILL HELP THE PATIENTS MORE EFFICIENTLY IN HOMOEOPATHIC MANAGEMENT.
THIS ANALYTICAL, INTERVENTIONAL UNCONTROLLED CLINICAL TRIAL WILL BE CARRIED OUT OVER A PERIOD OF 9 MONTHS AT BARODA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, VADODARA. THE STUDY WILL USE PURPOSIVE SAMPLING OF 30 PATIENTS, CLINICAL ASSESSMENT WILL BE DONE USING THE GERD Q SCORE SYSTEM. |