| CTRI Number |
CTRI/2026/03/105388 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Individualized Homoeopathy in Wound Healing |
|
Scientific Title of Study
|
A Randomized Placebo-Controlled Trial Evaluating the Effect of Individualized Homeopathic Medicine for Wound Healing. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1336-1958 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RITWICK SAHA |
| Designation |
UG STUDENT (B.H.M.S) |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Surgery,OPD NO- 03 AND 06,265,266, Acharya Prafulla chandra Road,Kolkata 700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9007606936 |
| Fax |
|
| Email |
ritwicksaha488@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANJAN ROY |
| Designation |
Associate Professor and HOD,Department of Surgery |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Surgery,OPD NO- 03 AND 06,265,266, Acharya Prafulla chandra Road,Kolkata 700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
7610990608 |
| Fax |
|
| Email |
dranjanroy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANJAN ROY |
| Designation |
Associate Professor and HOD,Department of Surgery |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Surgery,OPD NO- 03 AND 06,265,266, Acharya Prafulla chandra Road,Kolkata 700009
WEST BENGAL
700009
India |
| Phone |
7610990608 |
| Fax |
|
| Email |
dranjanroy@gmail.com |
|
|
Source of Monetary or Material Support
|
| THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, 265,266, Acharya Prafulla chandra Road,Kolkata 700009,WEST BENGAL,India |
|
|
Primary Sponsor
|
| Name |
THE CALCUTTA HOMOEPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
265,266, Acharya Prafulla chandra Road,Kolkata 700009 |
| Type of Sponsor |
Government medical college |
|
|
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 ANJAN ROY |
THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
Department of Surgery,OPD NO- 03 AND 06,265,266, Acharya Prafulla chandra Road,Kolkata 700009
Kolkata
WEST BENGAL |
7610990608
dranjanroy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, 265,266, Acharya Prafulla chandra Road,Kolkata 700009,WEST BENGAL,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T149||Unspecified injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical looking Palcebo with Concomitant care |
Identical-looking un medicated vehicles.
Dose: As required by the case.
Dressing using calendula lotion.
Both groups will receive identical basic wound care clean dressing with sterile dry gauze as concomitant care.
Duration of therapy-4 weeks of intervention for each patient.
Total duration of study-12 weeks. |
| Intervention |
Individualised Homoeopathic (IH) remedy in Centesimal potency with Concomitant care. |
Individualised Homoeopathic remedy based on totality of symptoms.
Dose: As required by the case in centesimal potency.
Dressing using calendula lotion.
Both groups will receive identical basic wound care clean dressing with sterile dry gauze as concomitant care.
Duration of therapy-4 weeks of intervention for each patient.
Total duration of study-12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Simple, clean wounds (traumatic or surgical)
2) Less than or equal to 5 cm in diameter
3) Wound onset within the last 72 hours
4) Consent to participate |
|
| ExclusionCriteria |
| Details |
1) Infected or chronic wounds like diabetic, pressure ulcers.
2) Immunocompromised conditions like HIV, chemotherapy.
3) Use of antibiotics or other healing agents on the wound.
4) Allergy to alcohol-based preparations. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound size (cm²) measurement done by using a ruler or transparent graph paper (Simple Planimetry). |
Baseline, Week 2 and Week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VISUAL ANALOGUE SCALE (VAS) for pain measurement (0-10) |
Baseline, Week 2 and Week 4 |
| Wound Healing Grading Scale (0–3) |
Baseline, Week 2 and Week 4 |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
16/03/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Wound healing is a complex, dynamic biological process involving the restoration of skin integrity following injury due to trauma, surgery, burns or chronic disease. Successful wound healing requires a coordinated sequence of haemostasis, inflammation, proliferation and remodelling, all of which can be disrupted by local or systemic factors. When the healing process is impaired or delayed, wounds may become chronic, leading to increased morbidity, risk of infection and reduced quality of life.This Double blind randomized placebo-controlled trial conducted at The Calcutta Homoeopathic Medical College and Hospital,kolkata aimed at providing evidence-based validation of Homoeopathy’s role as a supportive, integrative strategy in managing wounds particularly in cases where conventional therapy alone is insufficient or not well tolerated by enrolling 108 patients in 2:1 randomized ratio (Verum: Control). Primary outcome Measure will be Wound size (cm²) measurement done by using a ruler or transparent graph paper (Simple Planimetry) and Secondary Outcome measures will be Visual Analogue Scale (VAS) for pain measurement (0-10) and Healing Grading Scale (0–3) for Baseline, Week 2 and Week 4 for each patient for a total time period of 6 months.With proper ethical oversight and scientific rigor, the findings could advance integrative and personalized healthcare paradigms. |