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CTRI Number  CTRI/2025/07/089944 [Registered on: 01/07/2025] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Post-cholecystectomy syndrome and Homoeopathy 
Scientific Title of Study   Randomised comparative study of Homoeopathic individualized centesimal potencies vs LM-potencies in patients with Post-cholecystectomy syndrome with special reference to dyspepsia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Partha Pratim Pal 
Designation  Research Officer (Homoeopathy) Scientist - 2 
Affiliation  Central Council for Research in Homoeopathy 
Address  Dr Anjali Chatterji Regional Research Institute for Homoeopathy 50 Rajendra Chatterjee Road Department of Clinical Research Room no 5
Baranagar
North Twentyfour Parganas
WEST BENGAL
700035
India 
Phone  08910890779  
Fax    
Email  justdoit.partha007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Partha Pratim Pal 
Designation  Research Officer (Homoeopathy) Scientist - 2 
Affiliation  Central Council for Research in Homoeopathy 
Address  Dr Anjali Chatterji Regional Research Institute for Homoeopathy 50 Rajendra Chatterjee Road Department of Clinical Research Room no 5
Baranagar
North Twentyfour Parganas
WEST BENGAL
700035
India 
Phone  08910890779  
Fax    
Email  justdoit.partha007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Partha Pratim Pal 
Designation  Research Officer (Homoeopathy) Scientist - 2 
Affiliation  Central Council for Research in Homoeopathy 
Address  Dr Anjali Chatterji Regional Research Institute for Homoeopathy 50 Rajendra Chatterjee Road Department of Clinical Research Room no 5
Baranagar
North Twentyfour Parganas
WEST BENGAL
700035
India 
Phone  08910890779  
Fax    
Email  justdoit.partha007@gmail.com  
 
Source of Monetary or Material Support  
Director General, Central Council for Research in Homoeopathy 61-65, Institutional Area, Opp D block, Janakpuri, New Delhi - 110058 
 
Primary Sponsor  
Name  Director General, Central Council for Research in Homoeopathy 
Address  61-65, Institutional Area, Opp D block, Janakpuri, New Delhi - 110058 
Type of Sponsor  Research institution 
 
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 Partha Pratim Pal  Dr Anjali Chatterji Chatterji Regional Research Institute for Homoeopathy, Kolkata  Room no 5, Dr Anjali Chatterji Chatterji Regional Research Institute for Homoeopathy, Kolkata
North Twentyfour Parganas
WEST BENGAL 
08910890779

justdoit.partha007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee of Dr Anjali Chatterji Chatterji Regional Research Institute for Homoeopathy, Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K915||Postcholecystectomy syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Individualised Homeopathic medicines  The indicated homoeopathic medicine in 0/1 potency will be administered initially with frequent repetition as per the intensity of the symptom. One globule (poppy-seed size) of the medicine in the desired LM potency was dissolved in 120 ml of distilled water; containing 2.4 ml (2% v/v) of dispensing alcohol, premixed in it; followed by ten uniformly-forceful downward strokes given against the bottom of the phial. This solution will be given to the respective patient with the instructions regarding the dosage as follows: Before each dose, ten uniformly-forceful downward strokes to be given to the bottle held in the hand, on a firm surface. • To mix three tea spoonfuls (15 ml) of this solution with eight tea spoonfuls (40ml) of water in a separate clean glass and stir the solution well. • One tea spoonful (5 ml) of this solution would constitute one dose and this is to be taken as advised by the investigator. • The liquid remaining in the glass after taking this dose is to be discarded.  
Intervention  Individualised Homoeopathic medicines  IHM will be given to the patients in centesimal potency. Potency and dose will be decided as appropriate for the patient and will be as per the homoeopathic principles. Each dose of the selected medicine will be 4 globules (no 30) of cane sugar, medicated with the indicated medicine (preserved in 90 % v/v ethanol) to be taken orally on a clean tongue. The change of medicine and repetition shall be as per homoeopathic principles. Medicines will be procured from GMP certified firm 
 
Inclusion Criteria  
Age From  20.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  • Age: 20 years -60 years, Gender: male and female
• Patient underwent cholecystectomy (Open or Laparoscopic) at least minimum of 2 months ago and maximum of 20 years ago.
• Patient with features of dyspepsia with or without jaundice.
 
 
ExclusionCriteria 
Details  • Post-cholecystectomy syndrome cases arising due to biliary stricture, fistula, perforation, chronic pancreatitis, Cholangitis, Helicobacter pylori infection, retained or dropped stone.
• Incidental Gall Bladder Cancer (IGBC) after cholecystectomy
• Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Dyspepsia Severity Assessment Score  At baseline, 3rd month, 6th month, 9th month and 12th month 
 
Secondary Outcome  
Outcome  TimePoints 
The Gastrointestinal Quality of Life Index (GIQLI)   At baseline, 3rd month, 6th month, 9th month and 12th month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/08/2025 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [justdoit.partha@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Abdominal symptoms persist in up to 40% of patients after laparotomy cholecystectomy and biliary lithotripsy. Laparoscopic cholecystectomy is now the treatment of choice for symptomatic gallstone disease. However, no data exist as to the influence of laparoscopic cholecystectomy on symptoms1.Symptoms include biliary or non-biliary-like abdominal pain, dyspepsia, vomiting, gastrointestinal disorders, and jaundice, with or without fever and cholangitis. This group of abdominal symptoms which recur or persist after cholecystectomy is termed as Post-cholecystectomy syndrome (PCS). It may occur early during the post-operative period and if late it may manifest after months or years. Probably because of the uncertainty in nosographic definition, the reported prevalence of PCS ranges from very low and is 5to 40 %. Clinical experiences prove efficacy of Homoeopathy medicines in gastro-intestinal symptoms related to PCS as evident from Homoeopathic materia medica and published articles. Moreover, one of the aspects in fundamentals of Homoeopathy is Posology and in which the effect of individualized homoeopathic intervention in LM and CH potencies is always a dilemma i.e., which potency acts better. Both the scales of potency were discovered by Hahnemann, although the former scale of potency is the latest and were published posthumously. In this project we intend to compare the effectiveness of the two different scales of potencies in post cholecystectomy cases and for that 30 patients will be randomly selected in intervention and comparative group and based on Dyspepsia Severity Assessment Score at baseline, 3rd month, 6th month, 9th month and 12th month the evaluation will be done at the study centre i.e. Dr Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata. It is randomised (1:1), open labelled comparative trail. The generated results will undergo statistical analysis and will be published in scientific journal.

 
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