| CTRI Number |
CTRI/2024/06/069214 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effectiveness of homoeopathic remedy in centesimal potency and 50 millesimal potency for irritable bowel syndrome. |
|
Scientific Title of Study
|
Comparative effectiveness of individualised homoeopathic medicines in lm potencies and centesimal potencies for the management of irritable bowel syndrome: a prospective randomized clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhrajit Paul |
| Designation |
Postgraduate Traninee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Opd no 14, National Institute of Homoeopathy
Block GE, Sector III, Salt Lake, Kolkata, West Bengal
Sujara plot, Gopalmath, Durgapur, west bengal, Pin 713217
Kolkata
WEST BENGAL
700106
India |
| Phone |
7278377958 |
| Fax |
|
| Email |
paulsubhrajit007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gobind Narayan Gupta |
| Designation |
Assistant Professor, Department of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Opd no 14, National Institute of Homoeopathy
Block GE, Sector III, Salt Lake, Kolkata, West Bengal
Kolkata
WEST BENGAL
700106
India |
| Phone |
9163197805 |
| Fax |
|
| Email |
dr.gn05gupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gobind Narayan Gupta |
| Designation |
Assistant Professor, Department of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Opd no 14, National Institute of Homoeopathy
Block GE, Sector III, Salt Lake, Kolkata, West Bengal
Kolkata
WEST BENGAL
700106
India |
| Phone |
9163197805 |
| Fax |
|
| Email |
dr.gn05gupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata -700106, West
Bengal, India
|
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE, Sector III, Salt Lake, Kolkata -700106, West Bengal, India |
| 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 Gobind Narayan Gupta |
National Institute of Homoeopathy |
OPD no. 14, Department of Organon of Medicine and Homoeopathic Philosophy,
National Institute of Homoeopathy, GE BLOCK, Sector -3, salt lake, kolkata -n 700106
Kolkata
WEST BENGAL |
9163197805
dr.gn05gupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of the National Institute of Homoeopathy |
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 |
Centesimal potency will be given |
after proper case-taking and forming the totality individualized homoeopathy medicine will be given in Centesimal potency |
| Intervention |
LM potency will be given |
after proper case-taking and forming the totality individualised homoeopathy medicine will be given in LM potency |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients suffering from IBS as per Rome IV diagnostic criteria
b. Both sexes
c. Age 18-65 years
d. Patients willing to participate in the study and giving written informed consent.
e. Ability to Understand Bengali or Hindi or English |
|
| ExclusionCriteria |
| Details |
a. Any major gastrointestinal surgery in the last 6 months
b. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or lifethreatening illness affecting the quality of life or any organ failure.
c. Currently receiving standard therapy for IBS and/ or homoeopathic treatment for any
chronic condition(s)
d. Pregnant and lactating women
e. Self-reported immune compromised conditions
f. Substance abuse and/or dependence
g. Patients who are too sick for consultation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of increase or decrease in IBS-QOL questionnaire total score in patient
suffering from Irritable Bowel Syndrome
|
Baseline and every month up to 6 months of treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of increase or decrease in IBS-SSS questionnaire total score in patient
suffering from Irritable Bowel Syndrome
|
Baseline and every month up to 6 months of treatment. |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
01/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2024 |
| 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
|
The study will explore not only the symptomatic relief of IBS using IBS-QOL scores and IBS-SSS scores provided by the respective
potencies of Homoeopathic medicine but also consider broader aspects such as quality of life, psychological well-being,
and patient satisfaction. Through a comprehensive and randomized approach, this research
seeks to enhance our understanding of homoeopathic approaches to IBS but also provide
evidence-based guidance for practitioners in choosing between LM and centesimal potencies,
thus optimizing individualized treatment strategies for patients suffering from this challenging
condition. |