| CTRI Number |
CTRI/2025/06/089711 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of KENT Homoeopathic Repertory in treatment of Irritable Bowel Syndrome |
|
Scientific Title of Study
|
A Clinical Study On The Utility Of Kent Repertory In The Treatment 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 Bhuvan Kumar |
| Designation |
PG SCHOLAR, DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING |
| Affiliation |
RBTS Government Homoeopathic Medical College and HospitalMuzaffarpur, Bihar. |
| Address |
OPD-1-7 PG Building Room Number 08 RBTS Government Homoeopathic Medical College and Hospital, Muzaffarpur, Bihar, India
OPD- 1-7 and PG Building Room number 08 RBTS Government Homoeopathic Medical College and Hospital, Muzaffarpur, Bihar, India
Muzaffarpur
BIHAR
842002
India |
| Phone |
7258069269 |
| Fax |
|
| Email |
drbhuvank@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Kumar |
| Designation |
Reader, Department of Homoeopathic Repertory and Case taking |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
PG Building Room number 08, RBTS Government Homoeopathic Medical College and Hospital, Muzaffarpur, Bihar,India
PG Building Room number 08, RBTS Government Homoeopathic Medical College and Hospital, Muzaffarpur, Bihar, India
Muzaffarpur
BIHAR
842002
India |
| Phone |
9006930950 |
| Fax |
|
| Email |
drramkumar26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ram Kumar |
| Designation |
Reader, Department of Homoeopathic Repertory and Case taking |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
PG Building Room number 08, RBTS Government Homoeopathic Medical College and Hospital, Muzaffarpur, Bihar,India
PG Building Room number 08, RBTS Government Homoeopathic Medical College and Hospital, Muzaffarpur, Bihar, India
Muzaffarpur
BIHAR
842002
India |
| Phone |
9006930950 |
| Fax |
|
| Email |
drramkumar26@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS Government Homoeopathic Medical College and Hospital,Muzaffarpur, BIHAR, India , Pin 842002 |
|
|
Primary Sponsor
|
| Name |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
Ramdayalu Nagar, Muzaffarpur, Bihar, 842002, India |
| Type of Sponsor |
Government 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 Bhuvan Kumar |
RBTS Government Homoeopathic Medical College andHospital |
OPD Room Number-1,3,5,6,7 in Hospital Building
Ramdayalu Ngar, Muzaffarpur,Bihar,Pin -8420002
BIHAR
Muzaffarpur
BIHAR |
7258069269
drbhuvank@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe R.B.T.S. Government Homoeopathic Medical College and Hospital, Muzaffarpur,bihar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K582||Mixed irritable bowel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional Homoeopathic
Medicine |
Kent Homoeopathic Repertory is consulted for repertorozation and medicine will be prescribed.Potency will be used from 6C, 30C,200C,1M,10M. Medicine will be administrated by oral route. Follow up done in every 15-20 days. Study will be minimum 3 month for each subject |
| Comparator Agent |
NIL |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
.Patients following ROME IV criteria will be included
.Patients of both sexes will be included
.Patients of 25-40 years of age will included
.Patients of all religion and different socio- economic status will be included
.Patients who give consent for Homoeopathic treatment will be included
.Patients having no co-morbidity will be included
|
|
| ExclusionCriteria |
| Details |
.Patient suffering from any systemic illness will be excluded
.Age below 25 years and above 40 Years will be excluded
.Patient who do not give consent for Homoeopathic treatment will be excluded
.Patient having any pathological abnormality will be excluded
.Pregnancy condition will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected from the study that it will increase the scope of KENT Homoeopathic repertory in selecting homoeopathic medicines in the treatment of Gastro intestinal disordes especilally in Irritable Bowel Syndrome and will provide a good alternative to the conventional mode of treatment with no side effects. It will also bring statistically more significant changes in the ROME Criteria. |
3-4 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out group of homoeopathic medicines effective in managing the cases of Irritable Bowel Syndrome and To see the changes in Patient-Oriented
ROME Criteria |
3-4 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
08/07/2025 |
| 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 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
|
Irritable Bowel Syndrome is a chronic functional GI disorder characterised by symptoms like recurrent pain in abdomen / dsiscomfort associated with alter bowel habit either contipation or diarrhoea. Patients Get relief from presenting complain when homoeopathic medicine prescribed on the basis of symptoms similarity by using Kent homoeopathic repertory. |