| CTRI Number |
CTRI/2024/12/078667 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Homoeopathy in Irritable Bowel Syndrome |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic Medicines versus Asafoetida 30C in the management of Irritable Bowel Syndrome: A Single-Blind Randomized Controlled Trial |
| 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 Prabhjeet Kaur |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence colony, New Delhi
South
DELHI
110024
India |
| Phone |
7982460762 |
| Fax |
|
| Email |
pkprabhjeet73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohit Mathur |
| Designation |
Asst. Professor |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence colony, New Delhi
South
DELHI
110024
India |
| Phone |
9818449588 |
| Fax |
|
| Email |
drmohitmathur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabhjeet Kaur |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence colony, New Delhi
South
DELHI
110024
India |
| Phone |
7982460762 |
| Fax |
|
| Email |
pkprabhjeet73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Homoeopathic Medical College and Hospital, B-Block, Defence colony, New Delhi-110024 |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic Medical College and Hospital |
| Address |
B-Block, Defence colony, New Delhi-110024 |
| 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 Prabhjeet Kaur |
Nehru Homoeopathic Medical College and Hospital |
OPD-11, Department of Practice of Medicine, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi-110024
South
DELHI |
7982460762
pkprabhjeet73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nehru Homoeopathic Medical College and Hospital Institutional Ethics Committee |
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 |
Standard regimen (diet modification, lifestyle changes, stress management) plus Asafoetida 30C |
Patients in the control arm will receive the standard regimen for IBS management, along with Asafoetida 30C, as the control intervention. 30 patients will be enrolled in the comparator arm through random allocation using using
random number table method. Each patient will be subjected to a detailed history taking and physical examination. Asafoetida 30C once daily will be repeated for 2 weeks, along with the standard regimen for managing IBS, which includes, diet modifications such as low FODMAP diet, lifestyle modifications such as regular physical activity, adequate hydration, sufficient sleep, and stress management. Follow up will be taken at every 2 weeks, next dosage will be given according to principles of organon and individual susceptibility. The follow up of each patient will be taken at every 2 weeks interval. Each patient will receive treatment for a period of 12 weeks and outcome data will be collected in the form of IBS symptom severity scale and EQ-5D Questionnaire from baseline to 12 weeks of treatment. Data of IBS SSS and EQ-5D from baseline to 12 weeks of intervention, for each patient, will be analyzed for research purpose. |
| Intervention |
Standard regimen (diet modification, lifestyle changes, stress management) plus individualized homoeopathic medicines. |
Total 60 patients will be included in trial. Upon receiving patient’s consent to participate in the research project, he/she will be randomly allocated either to intervention or comparator arm using random number table
method. Only participants will be blind to the treatment allocation. Researcher will be aware of the treatment allocation. 30 patients will be enrolled in the experimental arm. Patients will be subjected to a detailed history taking and
physical examination. This will be followed by evaluation of patient’s symptoms and formation of symptom
totality. Repertorization will be done depending upon the case. Kent repertory 6th Indian edition will be used for the purpose of repertorization. A single Homoeopathic remedy will be selected based on the symptom analysis after considering totality of symptoms and repertorial result, along with the standard regimen for managing IBS, which includes, diet modifications such as low FODMAP diet, lifestyle modifications such as regular physical activity, adequate hydration, sufficient sleep, and stress management. The remedy will be prescribed in centesimal scale in the form of globules. Mode of administration will be oral. Potency selection will be based according to case presentation of the patient. The follow up of each patient will be taken at every 2 weeks interval. Each patient will receive treatment for a period of 12 weeks and outcome data will be collected in the form of IBS symptom severity scale and EQ-5D Questionnaire from baseline to 12 weeks of treatment. Data of IBS SSS and
EQ-5D from baseline to 12 weeks of intervention, for each patient, will be analyzed for research purpose. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Score of more than 75 on Irritable Bowel Syndrome- Symptom severity scale (IBS-SSS).
Patients giving written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients with other severe systemic illnesses, malignant disorders, autoimmune diseases
or any organic disease.
Patients above 50 years of age.
Any major surgery in the last 6 months.
Patients under other medication for the same complaint.
Patients with cognitive impairment.
Pregnant women and lactating mothers.
Patients who are already enrolled in some other study.
Patients who are not willing to give the consent. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Irritable Bowel Syndrome-Symptom Severity Scale (IBS-SSS) |
At baseline and after 12 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EQ-5D Questionnaire |
At baseline and after 12 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
10/01/2025 |
| 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
|
This is a Single-Blind Randomized Controlled Study to compare the efficacy of Individualized Homoeopathic Medicines and Asafoetida 30C in the management of Irritable Bowel Syndrome. 60 patients suffering from Irritable Bowel Syndrome fulfilling Rome IV criteria will be randomized into 2 groups, using Random number table method, consisting of 30 patients in each group. Study will be of 1 year duration. Improvement in symptoms of IBS will be assessed using IBS- Symptom Severity Scale and change in the quality of life of the patients will be assessed using EQ-5D Questionnaire.
RESEARCH QUESTION: What is the efficacy of Individualized Homoeopathic Medicines (IHMs) as compared to Asafoetida 30C in the management of Irritable bowel syndrome? Null hypothesis (H0): There is no significant difference between the two comparable groups, i.e. Individualized Homoeopathy Medicines (IHMs) and Asafoetida 30 in the management of Irritable Bowel Syndrome. Alternative hypothesis (HA): There is significant difference between the two comparable groups, i.e. Individualized Homoeopathy Medicines (IHMs) and Asafoetida 30 in the management of Irritable Bowel Syndrome.
AIM To assess the efficacy of Individualized Homoeopathic Medicines versus Asafoetida 30C in the management of irritable bowel syndrome.
OBJECTIVES 1. To find the role of Individualized Homeopathic Medicines (IHMs) in the management of irritable bowel syndrome and to list down the most indicated remedies. 2. To clinically verify the role of Asafoetida 30 C in the management of irritable bowel syndrome. 3. To compare the efficacy of Individualized Homeopathic Medicines (IHMs) versus Asafoetida 30C in the management of irritable bowel syndrome. 4. To assess the IBS patient taking treatment, based on change in signs and symptoms using Irritable Bowel Syndrome- Symptom Severity Scale (IBS-SSS) [Annexure-3] and change in Quality of life using EQ-5D Questionnaire.
Procurement of medicines: Pharmacy of Nehru Homoeopathic Medical College and Hospital. |