| CTRI Number |
CTRI/2025/06/088181 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Treatment of irritable bowel syndrome by homoeopathy |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in 50-millesimal
potency in adult patients suffering from Irritable Bowel Syndrome with its miasmatic analysis: A
Double-blind, Randomised, Placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1322-7033 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
IPSA ABHIPSA |
| Designation |
Post Graduate Trainee (Dept. of Organon of Medicine) |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
The Calcutta Homoeopathic Medical College and Hospital, 265-266, Acharya Prafulla Chandra Road, Kolkata Dept. of Organon of Medicine, OPD No.- 19 and Special OPD No. -21, 265-266, Acharya Prafulla Chandra Road, Kolkata Kolkata WEST BENGAL 700009 India |
| Phone |
9438061221 |
| Fax |
|
| Email |
ipsamoon.2497@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR JAYABRATA PAL |
| Designation |
Associate Professor, Dept. of Organon of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
The Calcutta Homoeopathic Medical College and Hospital, 265-266, Acharya Prafulla Chandra Road, Kolkata Dept. of Organon of Medicine, OPD No.- 19 and Special OPD No. -21, 265-266, Acharya Prafulla Chandra Road, Kolkata Kolkata WEST BENGAL 700009 India |
| Phone |
7679752020 |
| Fax |
|
| Email |
dr.jayabratapal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR JAYABRATA PAL |
| Designation |
Associate Professor, Dept. of Organon of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
The Calcutta Homoeopathic Medical College and Hospital, 265-266, Acharya Prafulla Chandra Road, Kolkata Dept. of Organon of Medicine, OPD No.- 19 and Special OPD No. -21, 265-266, Acharya Prafulla Chandra Road, Kolkata Kolkata WEST BENGAL 700009 India |
| Phone |
7679752020 |
| Fax |
|
| Email |
dr.jayabratapal@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College & Hospital, 265-266, Acharya Prafulla Chandra Road, Kolkata, 700009, West Bengal |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265-266, Acharya Prafulla Chandra Road, Kolkata, 700009, West Bengal |
| 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 |
| IPSA ABHIPSA |
The Calcutta Homoeopathic Medical College and Hospital |
Dept. of Organon of Medicine, Special OPD No-21, OPD No- 19,The Calcutta Homoeopathic Medical College and Hospital, 265-266, A.P.C Road, Kolkata Kolkata WEST BENGAL |
9438061221
ipsamoon.2497@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Comparator Agent |
Identical looking placebos with concomitant care. |
In placebo, one non-medicated globule of no.10 is to be
dissolved in 100 ml of distilled water, and 5 minims of rectified spirit are
added to it and mixed well to make 7 doses or as required. After 10 uniform
forceful downward strokes to the vial, each dose of 15ml is to be added in
45ml normal water in a clean cup and to be stirred well, from the mixture 5ml
is to be taken orally on clean tongue in empty stomach, and rest of the mixture
is to be discarded. Dosage and repetition will be done depending upon the
individual requirement of the case. |
| Intervention |
Individualised homoeopathic medicines in 50-millesimal potency with concomitant care. |
In 50-millesimal potencies, one medicated globule of no.10 is to be
dissolved in 100 ml of distilled water, and 5 minims of rectified spirit are
added to it and mixed well to make 7 doses regularly or as required. After 10
uniform forceful downward strokes to the vial, each dose of 15ml is to be
added in 45ml normal water in a clean cup and to be stirred well, from the
mixture 5ml is to be taken orally on clean tongue in empty stomach, and rest
of the mixture is to be discarded. Dosage and repetition will be done depending
upon the individual requirement of the case. Patients were advised to refrain
from eating, drinking, smoking, or brushing their teeth within 30 min of taking
the medicine. Total duration of therapy will be 3 months for each enrolled patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling Rome IV diagnostic criteria for IBS (recurrent abdominal
pain that occurs an average of at least 1 day/week and is associated with two
or more of the following three features: (1) related to defecation (relief or worsening), (2) associated with a change in frequency of stool, or (3)
associated with a change in form (appearance) of stool)
2. Literate patients with the ability to read Bengali, Hindi, and/or English. |
|
| ExclusionCriteria |
| Details |
1. Patients having clinical features like unexplained weight loss, bleeding PR,
and persistent diarrhoea.
2. Patients having disease symptoms secondary to organic causes like celiac
disease, Inflammatory bowel disease and lactose malabsorption, etc.
3. Any major gastrointestinal surgery in the last 6 months
4. Currently receiving standard therapy for IBS and/or homeopathic treatment
for any chronic condition(s) especially in last 6 weeks
5. Diagnosed cases of unstable psychiatric complaints or other systemic diseases
affecting the quality of life
6. Pregnant, lactating, and puerperal women
7. Self-reported immune-compromised conditions and
8. Substance abuse and/or dependence.
9. Simultaneous participation in any other clinical trial |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IBS- Severity Scoring System(IBS-SSS) |
At baseline, and every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IBS-Quality of Life(IBS-QOL) |
At baseline, and every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="93" Sample Size from India="93"
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)
|
15/06/2025 |
| 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 (IBS; ICD-11-DD91.08) is one of the most frequently encountered gastrointestinal disorders in clinical practice, presenting with abdominal pain, altered bowel habits, and absence of detectable organic pathology. The etiology of IBS is multifactorial, involving motility disorders, visceral hypersensitivity, brain-gut axis dysregulation, and psychosocial factors. Irritable Bowel Syndrome (IBS) is typically characterized by abdominal pain or discomfort, accompanied by altered bowel habits, which may include constipation, diarrhoea, or a combination of both. Patients with IBS often report additional symptoms such as bloating, abdominal distention, symptoms triggered by food intake, and changes in pain location and stool patterns over time. Since IBS is a symptom-based disorder, treatment goals focus on alleviating symptoms such as pain, bloating, cramping, and diarrhoea or constipation. It mainly affects young and female individuals, and it tends to overlap with other functional gastrointestinal diseases (FGIDs) and causing a huge burden on life and society’s economy. It is a chronic relapsing condition that affects up to 11% of the global population and 16.7–24.2% of the United States population. The prevalence of IBS in North Indian people is around 4%, which poses a considerable burden on rural adults. Overall reported prevalence in different parts of India varies from 4.2 to 14%. Despite the numerous publications on various IBS treatment strategies in modern medicine, there is no universally accepted protocol. Hence, satisfaction with modern treatment is often an unmet need for patients. IBS does not impose life-threatening complications, but it significantly affects the patient’s quality of life, impairing daily functioning and contributing to high work absenteeism, and imposes an economic burden on the health care system. Homoeopathy, being a holistic system of medicine, always treats the patients individually by acting in the psychosomatic sphere, making it very effective in cases of IBS, where physical symptoms and mental symptoms go hand in hand. IBS is a psychosomatic illness that affects both the body and the mind. IBS is brought on by psychological issues such as emotional stress, rage, fear, etc., as well as unusual sensitivity to particular foods. Homoeopathy emphasizes a holistic approach and addresses a patient’s interaction with their mind and body. Currently, there is no agreement on the best form of treatment for IBS. The homoeopathic system of medicine is based on a holistic approach in which both mental and physical symptoms are considered in each individual case, so we are able to find out the efficacy of Homoeopathy in the management of Irritable Bowel Syndrome. Also, 50-millesimal potencies compared with centesimal dynamization have more beneficial effects, with just sufficient homoeopathic aggravation required for the cure of the patient. Literature review reveals that homoeopathic treatment is effective in cases of IBS, with some conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn. Hence, through this study, we aimed to evaluate the role of individualised homoeopathic medicines in 50-millesimal potencies using the Irritable Bowel Syndrome-Symptom Severity Scale (IBS-SSS) and the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) scores as the primary and secondary outcome measures, respectively, at baseline and every month up to 3 months. |