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CTRI Number  CTRI/2025/06/088181 [Registered on: 03/06/2025] Trial Registered Prospectively
Last Modified On: 03/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Treatment of irritable bowel syndrome by homoeopathy 
Scientific Title of Study   Efficacy of individualized homoeopathic medicines in 50-millesimal potency in adult patients suffering from Irritable Bowel Syndrome with its miasmatic analysis: A Double-blind, Randomised, Placebo-controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1322-7033  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  IPSA ABHIPSA 
Designation  Post Graduate Trainee (Dept. of Organon of Medicine) 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  The Calcutta Homoeopathic Medical College and Hospital, 265-266, Acharya Prafulla Chandra Road, Kolkata
Dept. of Organon of Medicine, OPD No.- 19 and Special OPD No. -21, 265-266, Acharya Prafulla Chandra Road, Kolkata
Kolkata
WEST BENGAL
700009
India 
Phone  9438061221  
Fax    
Email  ipsamoon.2497@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR JAYABRATA PAL 
Designation  Associate Professor, Dept. of Organon of Medicine 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  The Calcutta Homoeopathic Medical College and Hospital, 265-266, Acharya Prafulla Chandra Road, Kolkata
Dept. of Organon of Medicine, OPD No.- 19 and Special OPD No. -21, 265-266, Acharya Prafulla Chandra Road, Kolkata
Kolkata
WEST BENGAL
700009
India 
Phone  7679752020  
Fax    
Email  dr.jayabratapal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR JAYABRATA PAL 
Designation  Associate Professor, Dept. of Organon of Medicine 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  The Calcutta Homoeopathic Medical College and Hospital, 265-266, Acharya Prafulla Chandra Road, Kolkata
Dept. of Organon of Medicine, OPD No.- 19 and Special OPD No. -21, 265-266, Acharya Prafulla Chandra Road, Kolkata
Kolkata
WEST BENGAL
700009
India 
Phone  7679752020  
Fax    
Email  dr.jayabratapal@gmail.com  
 
Source of Monetary or Material Support  
The Calcutta Homoeopathic Medical College & Hospital, 265-266, Acharya Prafulla Chandra Road, Kolkata, 700009, West Bengal 
 
Primary Sponsor  
Name  The Calcutta Homoeopathic Medical College and Hospital 
Address  265-266, Acharya Prafulla Chandra Road, Kolkata, 700009, West Bengal 
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 
IPSA ABHIPSA  The Calcutta Homoeopathic Medical College and Hospital  Dept. of Organon of Medicine, Special OPD No-21, OPD No- 19,The Calcutta Homoeopathic Medical College and Hospital, 265-266, A.P.C Road, Kolkata
Kolkata
WEST BENGAL 
9438061221

ipsamoon.2497@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  (1) ICD-10 Condition: K58||Irritable bowel syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical looking placebos with concomitant care.  In placebo, one non-medicated globule of no.10 is to be dissolved in 100 ml of distilled water, and 5 minims of rectified spirit are added to it and mixed well to make 7 doses or as required. After 10 uniform forceful downward strokes to the vial, each dose of 15ml is to be added in 45ml normal water in a clean cup and to be stirred well, from the mixture 5ml is to be taken orally on clean tongue in empty stomach, and rest of the mixture is to be discarded. Dosage and repetition will be done depending upon the individual requirement of the case. 
Intervention  Individualised homoeopathic medicines in 50-millesimal potency with concomitant care.  In 50-millesimal potencies, one medicated globule of no.10 is to be dissolved in 100 ml of distilled water, and 5 minims of rectified spirit are added to it and mixed well to make 7 doses regularly or as required. After 10 uniform forceful downward strokes to the vial, each dose of 15ml is to be added in 45ml normal water in a clean cup and to be stirred well, from the mixture 5ml is to be taken orally on clean tongue in empty stomach, and rest of the mixture is to be discarded. Dosage and repetition will be done depending upon the individual requirement of the case. Patients were advised to refrain from eating, drinking, smoking, or brushing their teeth within 30 min of taking the medicine. Total duration of therapy will be 3 months for each enrolled patient. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients fulfilling Rome IV diagnostic criteria for IBS (recurrent abdominal
pain that occurs an average of at least 1 day/week and is associated with two
or more of the following three features: (1) related to defecation (relief or worsening), (2) associated with a change in frequency of stool, or (3)
associated with a change in form (appearance) of stool)
2. Literate patients with the ability to read Bengali, Hindi, and/or English.  
 
ExclusionCriteria 
Details  1. Patients having clinical features like unexplained weight loss, bleeding PR,
and persistent diarrhoea.
2. Patients having disease symptoms secondary to organic causes like celiac
disease, Inflammatory bowel disease and lactose malabsorption, etc.
3. Any major gastrointestinal surgery in the last 6 months
4. Currently receiving standard therapy for IBS and/or homeopathic treatment
for any chronic condition(s) especially in last 6 weeks
5. Diagnosed cases of unstable psychiatric complaints or other systemic diseases
affecting the quality of life
6. Pregnant, lactating, and puerperal women
7. Self-reported immune-compromised conditions and
8. Substance abuse and/or dependence.
9. Simultaneous participation in any other clinical trial  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
IBS- Severity Scoring System(IBS-SSS)  At baseline, and every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
IBS-Quality of Life(IBS-QOL)  At baseline, and every month, up to 3 months 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
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)   15/06/2025 
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="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  

Irritable Bowel Syndrome (IBS; ICD-11-DD91.08) is one of the most frequently encountered gastrointestinal disorders in clinical practice, presenting with abdominal pain, altered bowel habits, and absence of detectable organic pathology. The etiology of IBS is multifactorial, involving motility disorders, visceral hypersensitivity, brain-gut axis dysregulation, and psychosocial factors. Irritable Bowel Syndrome (IBS) is typically characterized by abdominal pain or discomfort, accompanied by altered bowel habits, which may include constipation, diarrhoea, or a combination of both. Patients with IBS often report additional symptoms such as bloating, abdominal distention, symptoms triggered by food intake, and changes in pain location and stool patterns over time. Since IBS is a symptom-based disorder, treatment goals focus on alleviating symptoms such as pain, bloating, cramping, and diarrhoea or constipation. It mainly affects young and female individuals, and it tends to overlap with other functional gastrointestinal diseases (FGIDs) and causing a huge burden on life and society’s economy. It is a chronic relapsing condition that affects up to 11% of the global population and 16.7–24.2% of the United States population. The prevalence of IBS in North Indian people is around 4%, which poses a considerable burden on rural adults. Overall reported prevalence in different parts of India varies from 4.2 to 14%.

Despite the numerous publications on various IBS treatment strategies in modern medicine, there is no universally accepted protocol. Hence, satisfaction with modern treatment is often an unmet need for patients. IBS does not impose life-threatening complications, but it significantly affects the patient’s quality of life, impairing daily functioning and contributing to high work absenteeism, and imposes an economic burden on the health care system. Homoeopathy, being a holistic system of medicine, always treats the patients individually by acting in the psychosomatic sphere, making it very effective in cases of IBS, where physical symptoms and mental symptoms go hand in hand. IBS is a psychosomatic illness that affects both the body and the mind. IBS is brought on by psychological issues such as emotional stress, rage, fear, etc., as well as unusual sensitivity to particular foods. Homoeopathy emphasizes a holistic approach and addresses a patient’s interaction with their mind and body. Currently, there is no agreement on the best form of treatment for IBS. The homoeopathic system of medicine is based on a holistic approach in which both mental and physical symptoms are considered in each individual case, so we are able to find out the efficacy of Homoeopathy in the management of Irritable Bowel Syndrome. Also, 50-millesimal potencies compared with centesimal dynamization have more beneficial effects, with just sufficient homoeopathic aggravation required for the cure of the patient. Literature review reveals that homoeopathic treatment is effective in cases of IBS, with some conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn. Hence, through this study, we aimed to evaluate the role of individualised homoeopathic medicines in 50-millesimal potencies using the Irritable Bowel Syndrome-Symptom Severity Scale (IBS-SSS) and the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) scores as the primary and secondary outcome measures, respectively, at baseline and every month up to 3 months.

 
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