| CTRI Number |
CTRI/2025/11/097383 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ROLE OF HOMOEOPATHY IN CASE OF ACIDITY |
|
Scientific Title of Study
|
ROLE OF ROBINIA PSEUDACACIA IN CASE OF GERD ASSESSING THROUGH FREQUENCY SCALE FOR THE SYMPTOMS OF GERD- AN 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 |
DAKA JAYSAN BHIKHABHAI |
| Designation |
MD SCHOLAR |
| Affiliation |
RAJKOT HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
OPT TO HADMATIYA BUS STAND TA TANKARA DIS MORBI
Gondal RD Near Makkam chowk udhyog nagar colony Bhaktinagar Rajkot
360002
Rajkot
GUJARAT
363641
India |
| Phone |
9427728476 |
| Fax |
|
| Email |
dakajaysan277@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Sanja |
| Designation |
HOD & Professor HMM IN UG |
| Affiliation |
RAJKOT HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
Meghavi comple 7 Manhar plot
Mangada Rd rajkot
Gondal RD Near Makkam chowk udhyog nagar colony Bhaktinagar Rajkot
360002
Rajkot
GUJARAT
360002
India |
| Phone |
9825885350 |
| Fax |
|
| Email |
drrajeshsanja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DAKA JAYSAN BHIKHABHAI |
| Designation |
MD SCHOLAR |
| Affiliation |
RAJKOT HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
OPT TO HADMATIYA BUS STAND TA TANKARA DIS MORBI
Gondal RD Near Makkam chowk udhyog nagar colony Bhaktinagar Rajkot
360002
Rajkot
GUJARAT
363641
India |
| Phone |
9427728476 |
| Fax |
|
| Email |
dakajaysan277@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAJKOT HOMOEOPATHIC MEDICAL COLLEGE,SAINATH HOSPITAL,360002 |
|
|
Primary Sponsor
|
| Name |
SAINATH HOSPITAL |
| Address |
Gondal RD Near Makkam chowk udhyog nagar colony Bhaktinagar INDIA GUJRAT RANKOT
360002 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DAKA JAYSAN BHIKHABHAI |
SAINATH HOMOEOPATHIC HOSPITAL |
ROOM NO 101 MEDICINE DEPARTMENT MAKKAM CHOWK GONDAL ROAD RAJKOT GUJRAT INDIA
Rajkot
GUJARAT |
9427728476
dakajaysan277@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
ROLE OF ROBINIA PSEUDACACIA IN CASE OF GERD ASSESSING THROUGH FREQUENCY SCALE FOR THE SYMPTOMS OF GERD AN EXPERIMENTAL STUDY |
SELECTION OF MEDICINE & DOSAGE,INSTRUCTIONS WILL BE STRICTLY FOLLOWING THE HOMOEOPATHIC PRINCIPAL ACCORDING TO SUCEPTIBILITY OF THE PATIENTS AND THE SEAT OF DISEASE. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Evaluating the role of ROBINIA PSEUDACACIA in managing GERD |
|
| ExclusionCriteria |
| Details |
History of upper gi surgery, ppi or H2 blocker use in prior 4 weeks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction in frequency and severity of GERD symptoms |
BEGINING AND END OF TREATMENT - MONTHLY FOLLOW UP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the improvement in overall quality of life |
To evaluate the improvement in overall quality of life after 8,16,24 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/11/2025 |
| 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="0"
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
|
The study “Role of Robinia pseudacacia in cases of GERD assessing through FSSG scale” aims to evaluate the effectiveness of the homeopathic medicine Robinia pseudacacia in managing symptoms of Gastroesophageal Reflux Disease (GERD). The FSSG (Frequency Scale for the Symptoms of GERD) is used as an assessment tool to measure changes in both reflux and dyspeptic symptoms before and after treatment.
Results are expected to show a significant reduction in FSSG scores, indicating improvement in symptoms such as heartburn, acidity, regurgitation, and epigastric discomfort. This suggests that Robinia pseudacacia can be a useful homeopathic remedy for managing GERD cases effectively and safely. |