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CTRI Number  CTRI/2025/10/096324 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role Of Homoeopathic Medicines In Irritable Bowel Syndrome Mixed Type 
Scientific Title of Study   Effectiveness of individualised homoeopathic medicines in management of irritable bowel syndrome–mixed type (IBS-M): an open label, single arm, prospective, pre-post clinical study 
Trial Acronym  HOMIBS-M Study 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Avaneendra Trigunayat 
Designation  Post Graduate Trainee 
Affiliation  National Institute Of Homoeopathy 
Address  OPD 18,Department of Homoeopathic Materia Medica National Institute Of Homoeopathy, Block GE, Sector 3, Salt Lake Kolkata

Kolkata
WEST BENGAL
700106
India 
Phone  8889664959  
Fax    
Email  dr.avaneendratrigunayat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pratima Pal 
Designation  Associate Professor 
Affiliation  National Institute Of Homoeopathy 
Address  OPD 18,Department of Homoeopathic Materia Medica National Institute Of Homoeopathy, Block GE, Sector 3, Salt Lake Kolkata

Kolkata
WEST BENGAL
700106
India 
Phone  7679507608  
Fax    
Email  dr.pratimapal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pratima Pal 
Designation  Associate Professor 
Affiliation  National Institute Of Homoeopathy 
Address  OPD 18,Department of Homoeopathic Materia Medica National Institute Of Homoeopathy, Block GE, Sector 3, Salt Lake Kolkata

Kolkata
WEST BENGAL
700106
India 
Phone  7679507608  
Fax    
Email  dr.pratimapal@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Homoeopathy, Block GE, Sector 3, Salt Lake Kolkata Pin 700106 
 
Primary Sponsor  
Name  National Institute Of Homoeopathy 
Address  National Institute Of Homoeopathy, Block GE, Sector 3, Salt Lake Kolkata Pin 700106 
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 
Dr Avaneendra Trigunayat  National Institute Of Homoeopathy  OPD 18, Department of Homoeopathic Materia Medica National Institute Of Homoeopathy, Block GE, Sector 3, Salt Lake Kolkata
Kolkata
WEST BENGAL 		 8889664959

dr.avaneendratrigunayat@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K582||Mixed irritable bowel syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised Homoeopathic Medicine  Individualised homoeopathic medicines selected as per classical principles will be administered orally in suitable potency and repetition, with monthly follow-ups for six months, assessing symptom severity and quality of life. Total study duration is 1 year and 6 month. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)All religions and races irrespective of socioeconomic status.
2)Confirmed diagnosis of IBS-M as per Rome IV criteria.
3)Patient who understand and willing to give informed consent and adhere to follow up. 
 
ExclusionCriteria 
Details  1)History of IBD, coeliac disease, or colorectal cancer.
2)Use of antibiotics or probiotics in past 2 weeks.
3)Pregnant or lactating women.
4)Psychiatric illness affecting participation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in IBS Symptom Severity Score (IBS-SSS) and
Change in Quality of Life (QOL) 		 At Baseline, 3 Month and 6 Month 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   N/A 
Date of First Enrollment (India)   05/11/2025 
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   This research proposal by Dr. Avaneendra Trigunayat investigates the effectiveness of individualized homoeopathic medicines in managing Irritable Bowel Syndrome–Mixed Type (IBS-M) through an open-label, single-arm, prospective, pre-post clinical study involving 70 participants over 18 months. Conducted at the National Institute of Homoeopathy, Kolkata, and guided by Dr. Pratima Pal, the study aims to assess changes in symptom severity and quality of life using validated tools like IBS-SSS, IBS-QOL, and the Bristol Stool Form Scale. Given the fluctuating nature of IBS-M and limitations of conventional treatments, this study seeks to provide rigorous evidence supporting homoeopathy’s holistic and personalized approach, addressing both physical and psychosomatic dimensions of the disorder. 
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