| CTRI Number |
CTRI/2024/03/064838 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of irritable bowel syndrome |
|
Scientific Title of Study
|
A mixed-method research to develop diagnostic criteria for tubercular diathesis in
homoeopathy and its use in a subsequent double-blind, randomized, placebo-controlled
trial evaluating the efficacy of homoeopathic medicines in irritable bowel syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-6039 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushmita Lakra |
| Designation |
Postgraduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, 265, 266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
6290396119 |
| Fax |
|
| Email |
srlakra1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajat Chattopadhyay |
| Designation |
Principal and Administrator |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, 265, 266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Chattopadhyay |
| Designation |
Principal and Administrator |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, 265, 266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical and College Hospital, 265, 266 Acharya Prafulla
Chandra Road, Kolkata 700009 |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical and College Hospital |
| Address |
265, 266 Acharya Prafulla
Chandra Road, Kolkata 700009 |
| 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 Sushmita Lakra |
The Calcutta Homoeopathic Medical College and Hospital |
Medicine Outpatient Department no.21,265, 266 Acharya Prafulla Chandra Road, Kolkata 700009
Kolkata
WEST BENGAL |
6290396119
srlakra1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of The Calcutta Homoeopathic Medical College & Hospital |
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 |
| Comparator Agent |
Identical - looking placebos and
concomitant care
|
This arm will receive placebo,
indistinguishable in appearance from verum. Each dose of placebo shall consist of 4 globules (no. 40) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon
the individual requirement of the cases. All sundry items will be procured from a Good
Manufacturing Practice (GMP)
certified firm. All the enrolled patients of both groups will receive concomitant care in the
form of general management
which will include lifestyle management (LSM), namely avoiding foods which triggered the disease condition, like fat rich diet, cabbage, beans, legumes and coffee, advice to consume fibre. rich diet, sour curd and sufficient fluids daily. Route of administration- orally. Duration of therapy : 3 months. |
| Intervention |
Individualized homeopathic medicines in centesimal medicines plus concomitant care |
Intervention is planned as
administering indicated
homoeopathic remedy in
centesimal potencies, as
decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 4 globules (no.40) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised
to refrain from handling the
globules or from eating,
drinking, smoking or brushing
teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and the sundry items standard advice on lifestyle management (LSM), namely avoiding foods which triggered the disease condition, like fat rich diet, cabbage, beans, legumes and coffee, advice to consume fibre .
rich diet, sour curd and sufficient fluids daily. Route of administration- orally. Duration of therapy : 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age range: between 18-65 years
2. Either sex or transgender.
3. The patients suffering from IBS (ICD-10- CM K58.0) as per Rome IV diagnostic criteria,
i.e., recurrent abdominal pain on average of at least 1 day/ week in the last 3 months
associated with either of the following criteria related to defecation, associated with a
change in frequency of stool and or associated with a change in form of appearance of stool
4. Patient willingness and written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients not providing with informed consent voluntarily.
2. Diagnosed cases of unstable psychiatric complaints or systemic diseases affecting quality
of life.
3. Major gastro-intestinal surgery in last 6 months
4. For any chronic condition(s), pregnant, lactating and puerperal women
5. Currently ongoing usual standard therapy for IBS
6. Self-reported immune compromised conditions.
7. Substance abuse or dependence.
8. Vulnerable population–Unconscious, non-ambulatory, to oil for consultation, differently
abled, terminally ill or critically ill patients, mentally disabled people
9. Undergoing homoeopathic treatment for any chronic disease within last 6months
10. 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 |
| Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QOL) |
Every month up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Irritable Bowel Syndrome Symptom Severity Score(IBS-SSS) |
Every month up to 3 months |
| Measure Yourself Medical Outcome Profile (MYMOP2) |
Every month up to 3 months |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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 - 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
- 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 - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [srlakra1996@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Irritable bowel syndrome (IBS) (K 58.0 as per ICD 10) is a functional bowel disorder characterized by abdominal pain associated with altered bowel habits. Abdominal pain, discomfort, and changes in bowel habits without any structural or biochemical abnormalities are the hallmarks of the prevalent functional gastrointestinal illness known as irritable bowel syndrome or IBS. The overall stated prevalence in India varies between 4.2% and 14% depending on the region. It is one of the most important causes of absence from work, thereby causing a great economic burden. Homeopathy may have immense potential to offer in the successful treatment of Irritable Bowel Syndrome, but has remained seriously under-researched till date. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment Irritable Bowel Syndrome in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 82 adults who are suffering from the Irritable Bowel Syndrome at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital. Assessment will be done by Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL) score [Primary outcome], IBS-SSS (Irritable Bowel Syndrome Symptoms Severity Score), and MYMOP2 ( Measure Yourself Medical Outcome Profile) score [Secondary outcomes], all to be measured every month, up to 3 months. Comparative analysis will be carried out to detect group differences. The result will be published in scientific journal. |