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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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