| CTRI Number |
CTRI/2025/08/093424 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to see if understanding mind-body and emotional patterns helps in choosing the right homeopathic medicine for women with Irritable Bowel Syndrome |
|
Scientific Title of Study
|
A TWO ARM RANDOMIZED PLACEBO CONTROL TRIAL TO UNDERSTAND UTILITY OF PSYCHOSOMATIC PSYCHODYNAMIC STUDY FOR HOMOEOPATHIC CONSTITUTIONAL REMEDY FOR ADULT FEMALE WITH 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 |
Deeksha singh |
| Designation |
MD PGR( post graduate resident) |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College And Research Centre, Jaipur |
| Address |
OPD Medicine 2 Room number 30 Department Psychiatry 10- A, Sitapura Industrial Area, Tonk Road Goner Road, Sitapura industrial area , Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
8630252500 |
| Fax |
01412771778 |
| Email |
0016deeksha123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swarupananda Sarkar |
| Designation |
Associate Professor, Department of Psychiatry |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College And Research Centre, Jaipur |
| Address |
OPD Medicine 2 Room number 30 Department Psychiatry 10- A, Sitapura Industrial Area, Tonk Road Goner Road, Sitapura industrial area , Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9414483643 |
| Fax |
01412771778 |
| Email |
drsarkarhomoeopathy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swarupananda Sarkar |
| Designation |
Associate Professor, Department of Psychiatry |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College And Research Centre, Jaipur |
| Address |
OPD Medicine 2 Room number 30 Department Psychiatry 10- A, Sitapura Industrial Area, Tonk Road Goner Road, Sitapura industrial area , Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9414483643 |
| Fax |
01412771778 |
| Email |
drsarkarhomoeopathy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic Medical College And Reserch Centre,10- A, Sitapura Industrial Area, Tonk Road Goner Road, Sitapura industrial area , Sitapura Jaipur Rajasthan
RAJASTHAN
302022
India |
|
|
Primary Sponsor
|
| Name |
Swasthya Kalyan Homoeopathic Medical College And Research Centre, Jaipur |
| Address |
Swasthya Kalyan Homoeopathic Medical College And Reserch Centre,10- A, Sitapura Industrial Area, Tonk Road Goner Road, Sitapura industrial area , Sitapura Jaipur Rajasthan
RAJASTHAN
302022
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Swarupananda Sarkar |
Swasthya Kalyan Homoeopathic Medical College And Reserch Centre |
OPD Medicine 2 Room number 30 Department Psychiatry 10- A, Sitapura Industrial Area, Tonk Road Goner Road, Sitapura industrial area , Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN |
9414483643
drsarkarhomoeopathy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKHMCIEC |
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 |
Homoeopathic Medicines |
4 pill HS
Pill number 40
route of drug administration sublinguial |
| Comparator Agent |
Placebo
|
4 pill HS
Pill number 40
route of drug administration sublinguial |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed case of IBS
Must fulfil ROME IV diagnostic criteria
Minimum 3 months of continuous IBS symptoms
Participants must exhibit psychosomatic or psychodynamic features, identified through a brief psychological interview or screening
|
|
| ExclusionCriteria |
| Details |
Presence of any organic gastrointestinal disease
Diagnosed with severe psychiatric disorder- Schizophrenia, Bipolar Disorder, Severe Depression requiring hospitalization or drug therapy
Pregnant or breastfeeding females
On long term corticosteroids, opioids, or other medications
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify psychosomatic and psychodynamic patterns in adult females suffering from Irritable Bowel Syndrome (IBS). |
12 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To select individualized homoeopathic constitutional remedies based on psychosomatic-psychodynamic evaluation |
12 MONTH |
| To compare the effectiveness of the individualized homoeopathic remedy with a placebo in managing IBS symptoms |
12 MONTH |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
29/08/2025 |
| 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 two arm randomized single blind , placebo controlled clinical trail at Swasthya Kalyan homoeopathic college , Jaipur to assess the role of psychosomatic - psychodynamic understanding in selecting individualized homoeopathic remedies for adult females with IBS diagnosed by ROME IV criteria . After screening and consent , participants will be randomized to receive either individualized homeopathy or placebo for 3 months with regular follow up. Symptom change will be measured using IBS SSS. The study expects significant improvement in IBS symptoms with individualized homoeopathic management |