| CTRI Number |
CTRI/2019/11/021916 [Registered on: 07/11/2019] Trial Registered Prospectively |
| Last Modified On: |
07/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Homeopathic medicines for problems related to recurrent stool |
|
Scientific Title of Study
|
An open-label, Randomized, Placebo-controlled Trial to Evaluate the Efficacy of Gambogia and Individualized Homoeopathic Medicines in Irritable Bowel Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1242-8670 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sourav Das |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Materia Medica, OPD No. 12, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
|
| Fax |
|
| Email |
souravnih@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Usha Ghelani Uchat |
| Designation |
Reader |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Materia Medica, OPD No. 12, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
9830966265 |
| Fax |
|
| Email |
dr.ushauchatnih2017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Usha Ghelani Uchat |
| Designation |
Reader |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Materia Medica, OPD No. 12, Block GE, Sector III, Salt Lake
WEST BENGAL
700106
India |
| Phone |
9830966265 |
| Fax |
|
| Email |
dr.ushauchatnih2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; 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 |
| Sourav Das |
National Institute of Homoeopathy |
Dept. of Materia Medica, OPD room no. 12, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL |
8346808824
souravnih@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K580||Irritable bowel syndrome with diarrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homeopathic medicine Gambogia in centesimal potencies |
Intervention is planned as administering homeopathic medicine Gambogia in centesimal potencies. In centesimal scale, each dose shall consist of 6-8 medicated globules (no. 20) of cane sugar, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. The medicines have been procured from a Good Manufacturing Practice (GMP)-certified firm. The patients will be advised to avoid foods which trigger the disease condition like fat diet, cabbage, beans and legumes, to consume fibre rich diet, sour curd and sufficient fluid daily, and to practice yoga, meditation, and exercises daily. Duration of therapy: 3 months. |
| Comparator Agent |
Individualized homeopathic medicines in centesimal potencies |
Individualized homeopathic medicines will be prescribed in centesimal potencies. Each dose shall consist of 6-8 medicated globules (no. 20) of cane sugar, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. The medicines have been procured from a Good Manufacturing Practice (GMP)-certified firm. The patients will be advised to avoid foods which trigger the disease condition like fat diet, cabbage, beans and legumes, to consume fibre rich diet, sour curd and sufficient fluid daily, and to practice yoga, meditation, and exercises daily. Duration of therapy: 3 months. |
| Comparator Agent |
Placebo, indistinguishable in appearance from verum |
Each dose of placebo will be identical to centesimal scale medicines in appearance, but are non-medicated globules, moistened with 90% v/v ethanol. The patients will be advised to avoid foods which trigger the disease condition like fat diet, cabbage, beans and legumes, to consume fibre rich diet, sour curd and sufficient fluid daily, and to practice yoga, meditation, and exercises daily. Duration of therapy: 3 months |
|
|
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) Literate patients with ability to read Bengali and/or English
e) Patients willing to participate in the study and giving written informed consent. |
|
| ExclusionCriteria |
| Details |
a) Patients who are too unwell to take part
b) Inability to read patient information sheets and/or denied consent to take part
c) Diagnosed cases of unstable psychiatric complaints or other systemic diseases affecting quality of life
d) Any major gastro-intestinal surgery in last 6 months
e) Currently receiving standard therapy for IBS and/or homeopathic treatment for any chronic condition(s)
f) Pregnant and lactating women
g) Self-reported immune compromised conditions
h) Substance abuse and/or dependence |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IBS Quality of Life questionnaire |
Baseline, every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IBS symptom severity score |
Baseline, every month, up to 3 months |
| EQ-5D-5L questionnaire score and VAS measure |
Baseline, every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
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)
|
18/11/2019 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None yet; to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Irritable Bowel Syndrome (IBS) is one of the most frequently encountered gastro-intestinal disorders globally, distressing 10-20% of the adult population. The prevalence is 6-22% in the Western countries, although it is likely to be lower and ranges from 2-17% in the Eastern countries. The prevalence of IBS in North Indian people is around 4% where it poses a considerable burden on the rural adults. Early studies from Asia reported a prevalence of IBS below 5%. IBS is characterized by recurrent pain abdomen, distension, altered bowel movement (constipation, diarrhea, or both), and a multitude of gastrointestinal complaints. Severe IBS can significantly alter quality of life, disrupt daily activities, and result in inflated healthcare costs. Homeopathy research evidences in IBS remain compromised. We aimed to evaluate its efficacy beyond mere placebo effect in blinded and randomized design by using validated outcome measures. In this open-label, randomized, placebo-controlled, three parallel arms, clinical trial, 111 eligible patients suffering from IBS will be randomized to receive either homeopathic medicine Gambogia (n=37) in centesimal potencies, or individualized homeopathic medicines in centesimal potencies (n=37), or identical looking placebo (n=37). The patients will be advised to avoid foods which trigger the disease condition like fat diet, cabbage, beans and legumes, to consume fibre rich diet, sour curd and sufficient fluid daily, and to practice yoga, meditation, and exercises daily. Duration of therapy will be 3 months. IBS-QOL questionnaire, IBS Symptoms Severity Score, and EQ-5D-5L questionnaire score and VAS measures will be assessed at baseline, and every month up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. |