| CTRI Number |
CTRI/2025/10/095821 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on Irritable Bowel Syndrome treatment using Boger Boenninghausens characteristics and repertory. |
|
Scientific Title of Study
|
The Clinical Utility Of Boger Boenninghausens Characteristics and Repertory in the Management of Irritable Bowel Syndrome |
| 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 Ancin A N |
| Designation |
Junior Resident Department of Homoeopathic Repertory and Case Taking |
| Affiliation |
White Memorial Homoeopathy Medical College, Attoor |
| Address |
Department of Homoeopathic Repertory and case taking White memorial Homoeo medical college and hospital Attoor Veeyanoor Kanniyakumari district
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
8300913983 |
| Fax |
|
| Email |
ancinan1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR R K DOMININ RAJ |
| Designation |
PROFESSOR Department of Homoeopathic Repertory and Case Taking |
| Affiliation |
White Memorial Homoeopathy Medical College, Attoor |
| Address |
Department of Homoeopathic Repertory and case taking White memorial Homoeo medical college and hospital Attoor Veeyanoor Kanniyakumari district
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9447654467 |
| Fax |
|
| Email |
drdomininrajrk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR R K DOMININ RAJ |
| Designation |
PROFESSOR Department of Homoeopathic Repertory and Case Taking |
| Affiliation |
White Memorial Homoeopathy Medical College, Attoor |
| Address |
Department of Homoeopathic Repertory and case taking White memorial Homoeo medical college and hospital Attoor Veeyanoor Kanniyakumari district
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9447654467 |
| Fax |
|
| Email |
drdomininrajrk@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL ATTOOR KANNIYAKUMARI TAMILNADU |
|
|
Primary Sponsor
|
| Name |
Department of Homoeopathic Repertory and Case Taking,White Memorial Homoeopathy Medical College |
| Address |
White Memorial Homoeopathy Medical College Attoor Kanniyakumari Tamilnadu |
| 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 |
| Dr Ancin A N |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING OPD UNITS ,HEALTH CAMPS AND PERIPHERAL CENTERS , KANNIYAKUMARI TAMILNADU
Kanniyakumari
TAMIL NADU |
8300913983
ancinan1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL ETHICS COMMITTEE WMHMCH-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K58||Irritable bowel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic medicine |
Homoeopathic Medicine selected based on symptom similarity will be administered to the patients in proper dose potency and repetition of medicine according to the homoeopathic principle. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age group from 35 to 50 years.
Sex: Male & Female
All cases that fit into ROME 1V diagnostic criteria.
|
|
| ExclusionCriteria |
| Details |
Cases that do not satisfy the ROME IV criteria.
Patient who are already under treatment for Gastrointestinal disorders.
Pregnant and lactation women.
Patients suffering from other systemic illness who are under medication.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Improvement will be done by IBS-SSS Before and after treatment.Outcome will be classified as follows:
• MARKED IMPROVEMENT: More than 75% score
• MODERATE IMPROVEMENT: 40-75%
• MILD IMPROVEMENT: 5-40%
• NO IMPROVEMENT:Less than 5%
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO understanding The utility of Boger Boenninghusens Characteristics and Repertory. |
6 months |
|
|
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)
|
05/12/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ancinan1998@gmail.com].
- For how long will this data be available start date provided 12-09-2025 and end date provided 05-09-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
To assess the relief symptoms in irritable bowel syndrome and their changes in level score after homoeopathic treatment using Boger Boenninghausen’s characteristics and repertory with individualised homoeopathy medicine with two weeks once follow up . |