| CTRI Number |
CTRI/2025/09/095308 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Can Homoeopathy Help Relive Functional Indigestion? A Study on Symptoms Relife Using Anti Miasmatic Medicine. |
|
Scientific Title of Study
|
A Clinical Study On Homoeopathic Approach To Cases Of Functional Dyspepsia With Miasmatic Evaluation And Study
Effectiveness Of Anti Miasmatic Medicine. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEHTA JINESHBHAI MUKESHBHAI |
| Designation |
PG SCHOLAR |
| Affiliation |
RAJKOT HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
1 SARDARNAGAR WEST
SHARAD APARTMENT
BLOCK 12 3RD FLOOR
OPP RAILWAY TRACK
RAJKOT
Department Medicine
Room No 101
GONDAL ROAD
NEAR MAKKAM CHOWK
UDYOG NAGAR COLONY
BHAKTINAGAR
RAJKOT
Rajkot
GUJARAT
360001
India |
| Phone |
8347143875 |
| Fax |
|
| Email |
Jineshmehta56789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BIBHU PRASAD PANDA |
| Designation |
PROFESSOR DEPARTMENT OF ORGANON OF MEDICINE |
| Affiliation |
RAJKOT HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
GONDAL ROAD
NEAR MAKKAM CHOWK
UDYOG NAGAR COLONY
BHAKTINAGAR
RAJKOT
Department Medicine
Room No 101
GONDAL ROAD
NEAR MAKKAM CHOWK
UDYOG NAGAR COLONY
BHAKTINAGAR
RAJKOT
Rajkot
GUJARAT
360002
India |
| Phone |
9426977448 |
| Fax |
|
| Email |
bibhuprasad.panda38449@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
MEHTA JINESHBHAI MUKESHBHAI |
| Designation |
PG SCHOLAR |
| Affiliation |
RAJKOT HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
1 SARDARNAGAR WEST
SHARAD APARTMENT
BLOCK 12 3RD FLOOR
OPP RAILWAY TRACK
RAJKOT
Department Medicine
Room No 101
GONDAL ROAD
NEAR MAKKAM CHOWK
UDYOG NAGAR COLONY
BHAKTINAGAR
RAJKOT
Rajkot
GUJARAT
360001
India |
| Phone |
8347143875 |
| Fax |
|
| Email |
Jineshmehta56789@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College Gujarat India 360002 |
|
|
Primary Sponsor
|
| Name |
Sainath Hospital |
| Address |
Gondal Road Near Makkam Chowk Udyog Nagar Colony Rajkot Gujarat India 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 |
| DrJinesh Mukeshbhai Mehta |
Sainath Homoeopathic Hospital |
101 Medicine Department
Gondal Road Near Makkam Chowk Udyog Nagar Colony Bhaktinagar Rajkot Gujarat India 360002
Rajkot
GUJARAT |
8347143875
Jineshmehta56789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH - RAJKOT HOMOEOPATHIC MEDICAL COLLEGE PARUL UNIVERSITY GUJARAT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A Clinical Study On Homoeopathic Approach To Cases Of Functional Dyspepsia With Miasmatic Evaluation And Study Effectiveness Of Anti Miasmatic Medicine |
A Functional Dyspepsia Is a Chronic Condition diagnosed by Rome iv Criterria and through
Holistic Homoeopathic Approach With Miasmatic Evaluation And Anti Miasmatic Medicine condition Of Functional Dyspepsia Very Well Improves |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
CLINICAL DIAGNOSIS USING ROME IV CRITERIA
WILLING TO TAKE HOMOEOPATHIC MEDICINE AND PROVIDE INFORMED CONSENT
ABLE TO COMPREHEND AND RESPOND TO NEPEAN DYSPEPSIA INDEX QUESTIONNAIRE |
|
| ExclusionCriteria |
| Details |
PatientWith Organic And Systemic illness
Patient On Medication Known To Cause Functional Dyspepsia and Other GastroIntestinal Side Effect
Psychiatric And Cognitive Disorder
Patient Who Want To Take Other Systwm Medicine Together
Patient With Past or Recent Abdominal Surgery
Pregnant And Lactating Women
Alcoholics and Smoker
Patient Unable or Not Willing To Complete Follow Up |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE THE EFFECTIVENESS OF INDIVIDUALIZED ANTI MIASMATIC HOMOEOPATHIC MEDICINE IN MANAGING SYMPTOMS OF FUNCTIONAL DYSPEPSIA USING NEPEAN DYSPEPSIA INDEX |
4 Week
8 Week
12 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO EVALUATE MIASMATIC BACKGROUND IN EACH CASE OF FUNCTIONAL DYSPEPSIA.
TO IDENTIFY MAINTAINING CAUSE AND OBSERVE THE IMPACT OF REMOVING IT AND MANAGING ACCESSORY CIRCUMSTANCES |
4 Week
8 Week
12 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)
|
06/10/2025 |
| 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
|
A Functional Dyspepsia Is a Chronic Condition Diagnosed By Rome iv CriteriaIdentification Of Maintaining Cause and Study Of Accessory Circumstances is Having Important Role Functional Dyspepsia Affects Quality Of Life A Holistic Homoeopathic Approach with Miasmatic Evaluation and Anti Miasmatic Medicine Is Essential For Long Lasting Improvement |