CTRI Number |
CTRI/2017/05/008480 [Registered on: 04/05/2017] Trial Registered Prospectively |
Last Modified On: |
28/08/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Homeopathy |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Bowel disorder and its homoeopathic treatment |
Scientific Title of Study
|
An open-label randomized clinical study for the comparative effectiveness of constitutional homoeopathic medicine with Dysentery Compound in cases of Irritable Bowel Syndrome |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
U1111-1196-1004 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Laijun Nahar |
Designation |
Postgraduate Trainee |
Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
Address |
OPD No. 12, Dept. of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake
Kolkata WEST BENGAL 700106 India |
Phone |
7980274752 |
Fax |
|
Email |
laijun786@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Swapan Paul |
Designation |
Lecturer, Dept. of Homoeopathic Materia Medica |
Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
Address |
Dept. of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake
Kolkata WEST BENGAL 700106 India |
Phone |
9830148968 |
Fax |
|
Email |
drspaul.2007@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Swapan Paul |
Designation |
Lecturer, Dept. of Homoeopathic Materia Medica |
Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
Address |
Dept. of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake
WEST BENGAL 700106 India |
Phone |
9830148968 |
Fax |
|
Email |
drspaul.2007@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 Ministry of AYUSH Govt of India |
Address |
Block GE, Sector III, Salt
Lake, Kolkata, West Bengal 700106, 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 |
Laijun Nahar |
National Institute of Homoeopathy, Govt. of India |
OPD 12, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata, West Bengal 700106, India; Monday to Saturday, 9
am to 2 pm Kolkata WEST BENGAL |
7980274752
laijun786@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 |
Irritable Bowel Syndrome, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Dysentery Compound in centesimal or 50 millesimal potencies |
In centesimal potencies, each dose shall consist of 4 cane sugar globules medicated with a single drop of Dysentery Compound in required potencies, preserved in 88% v/v ethanol. In 50 millesimal
potencies, a single medicated cane sugar globule of poppy seed size (no.10) dissolved in 50 ml distilled water with addition of 2 drops of 88% v/v ethanol, 10 doses marked on the vial, each dose of 5 ml to be
taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of
this liquid orally, and to discard rest of the liquid in the cup. Repetition 24, 12 or 8 hourly or even oftener, depending upon the individual requirement of the case. Each dose to be taken orally on clean tongue in empty stomach. Duration of therapy: 3 months |
Intervention |
Individualized homeopathic medicine in centesimal or 50 millesimal potencies |
In centesimal potencies, each dose shall consist of 4
cane sugar globules medicated with a single drop of the indicated medicine, preserved in 88% v/v ethanol. In 50 millesimal
potencies, a single medicated cane sugar globule of poppy seed size (no.10) dissolved in 50 ml distilled water with addition of 2 drops of 88% v/v ethanol, 10 doses marked on the vial, each dose of 5 ml to be
taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of
this liquid orally, and to discard rest of the liquid in the cup. Repetition 24,
12 or 8 hourly or even oftener, depending upon the individual requirement of the case. Each dose to be taken orally on clean
tongue in empty stomach.
Duration of therapy: 3 months |
|
Inclusion Criteria
Modification(s)
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Age 18 to 65 years
2. Both sexes
3. Symptomatic IBS for at least 2 days/week over 3 months
4. IBS diagnosed and sub-typed as per Rome III criteria |
|
ExclusionCriteria |
Details |
1. Patients who are too sick for consultation
2. Unable to read patient information sheets and/or not giving consent to join the study
3. Diagnosed cases of unstable mental or psychiatric illness or other systemic disease affecting quality of life
4. Major gastro-intestinal surgery in last 6 months
5. Currently receiving standard therapy for IBS and/or undergoing homoeopathic treatment for chronic condition(s)
6. Pregnant and lactating women
7. Self-reported immune-compromised state
8. Substance abuse and/or dependence |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
IBS Quality of Life (IBS-QOL) questionnaire |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
None |
Not applicable |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
15/05/2017 |
Date of Study Completion (India) |
07/12/2017 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Irritable bowel syndrome (IBS) is the most common gastrointestinal disorder worldwide characterized by recurrent abdominal pain, bloating, altered bowel function (constipation, diarrhoea, or both), and a myriad of gastrointestinal symptoms. Its prevalence ranges between 10-15% in Western countries, 6.5-10.1% in Asian countries, and around 4% in North India, where it poses a significant burden on the rural adults and reduces the quality of life. Severe IBS can significantly reduce quality of life, disrupt activities of daily life, and result in exorbitant healthcare costs. In the absence of a reliable biologic marker of IBS, it has been challenging to develop well-targeted, effective IBS drugs and optimal endpoints for clinical trials. Due to unsatisfactory results from conventional treatment of IBS, Complementary and Alternative Medicine (CAM) modalities are increasingly becoming popular treatment alternatives. Unfortunately, most of the CAM clinical trials, including that of homoeopathy, have been of poor quality, and the efficacy of these therapies have not been adequately elucidated. In this project, we intend to evaluate the comparative efficacy of individualized homoeopathic treatment and treatment with a specific medicine Dysentery Compound in 60 patients suffering from IBS using IBS quality of life questionnaire over 3 months at the National Institute of Homoeopathy, Kolkata, West Bengal, India from May 2017 onward. It is an open, prospective, randomized, parallel arm trial. The generated results will undergo statistical analysis and will be published in scientific journal. |