| CTRI Number |
CTRI/2025/12/098725 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving IBS Symptoms in Working Professionals Through Individualized Homeopathy |
|
Scientific Title of Study
|
UTILITY OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE SELECTED USING KENT REPERTORY IN MANAGING PATIENTS OF IRRITABLE BOWEL SYNDROME HAVING OCCUPATIONAL STRESS |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VANDANA NARESH KHEMANI |
| Designation |
PG Scholar |
| Affiliation |
Jawaharlal Nehru Homoeoopathic Medical College and Hospital |
| Address |
OPD Room number 110, Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University, Waghodia
Vadodara GUJARAT 391760 India |
| Phone |
7069676384 |
| Fax |
|
| Email |
vandanakhemani0701@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jigneshkumar Patel |
| Designation |
BHMS, MD Homoeopathy, HOD ( Homoeoopathic Repertory and Case taking |
| Affiliation |
Jawaharlal Nehru Homoeoopathic Medical College and Hospital |
| Address |
Department of Homoeoopathic Repertory and Case taking, Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University, Waghodia
Vadodara GUJARAT 391760 India |
| Phone |
9909949221 |
| Fax |
|
| Email |
jignesh.patel79013@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr VANDANA NARESH KHEMANI |
| Designation |
Pg scholar |
| Affiliation |
Jawaharlal Nehru Homoeoopathic Medical College and Hospital |
| Address |
OPD Room number 110, Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University, Waghodia
Vadodara GUJARAT 391760 India |
| Phone |
7069676384 |
| Fax |
|
| Email |
vandanakhemani0701@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Waghodiya. Vadodara, Gujarat. 391760 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Waghodia, Vadodara, Gujarat, India, 391760 |
| 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 VANDANA NARESH KHEMANI |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
OPD Room number 110, Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Waghodia Vadodara GUJARAT Vadodara GUJARAT |
7069676384
vandanakhemani0701@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic Medical College and Hospital |
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 |
Individualised Homoeopathic Medicine selected by Homoeoopathic cardinal principles for 4 months in each patient |
| Comparator Agent |
No comparator agent |
As this is single arm study |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
- Patients aged 22-50 years, Having occupational stress of mild range assessed through WSS ( workplace stress scale )
- Patients diagnosed with irritable bowel syndrome (IBS) as per Rome IV criteria.
- Patients who give written informed consent |
|
| ExclusionCriteria |
| Details |
- Patients with organic gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease, malignancy).
- Patients with uncontrolled systemic illnesses (e.g., diabetes, hypertension, renal/liver failure).
- Patients currently on other long-term treatment for IBS
- Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Mild improvement
Moderate improvement
Clinically significant improvement
Status quo / negligible or no improvement
Any increase in IBS-SSS or WSS score will be counted as worse |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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
|
Irritable Bowel Syndrome IBS is a chronic functional gastrointestinal disorder affecting about 4.1 percent of the global population and 4.2 to 7.5 percent of people in India. It causes abdominal pain, disturbed bowel habits, reduced quality of life, and lower work productivity. Research shows a strong link between IBS and psychological factors such as stress, anxiety, and occupational pressure. Homeopathy has shown promising results in managing chronic functional disorders like IBS, especially when the treatment is individualized. Previous studies have reported significant improvement when remedies are selected based on the totality of symptoms. However, very few studies have used Kents Repertory in a structured way, particularly for patients with stress related or occupation related IBS. This study aims to evaluate the usefulness of individualized homoeopathic medicines selected through Kent repertory in patients suffering from IBS with occupational stress. It also aims to study the relationship between IBS severity and work stress levels and to compare IBS SSS and Work Stress Scale scores before and after treatment. Patients will be assessed every 15 days over a period of four months to observe progressive changes. The study hopes to provide evidence for an integrated homeopathic approach in psychosomatic conditions by combining repertorial analysis, individualized prescribing, and stress assessment. |