| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [justdoit.partha@gmail.com].
- 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.
- 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. |