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CTRI Number  CTRI/2024/03/063897 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 24/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathic medicines for wrist ganglion 
Scientific Title of Study   A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in reducing the lesion size of dorsal wrist ganglion in adults 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1304-0204  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Raguram 
Designation  Postgraduate Trainee 
Affiliation  D. N. De Homoeopathic Medical College and Hospital 
Address  Dept. of Repertory, OPD room no. PG3, 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal- 700046

Kolkata
WEST BENGAL
700046
India 
Phone  9080395909  
Fax    
Email  raguram9497@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajat Kumar Pal 
Designation  Professor and Head 
Affiliation  D. N. De Homoeopathic Medical College and Hospital 
Address  Dept of Repertory, OPD room no. PG3, 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  9433130996  
Fax    
Email  drrajatkumarpal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajat Kumar Pal 
Designation  Professor and Head 
Affiliation  D. N. De Homoeopathic Medical College and Hospital 
Address  Dept of Repertory, OPD room no. PG3, 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  9433130996  
Fax    
Email  drrajatkumarpal@gmail.com  
 
Source of Monetary or Material Support  
D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046 
 
Primary Sponsor  
Name  D. N. De Homoeopathic Medical College and Hospital 
Address  12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Raguram  D. N. De Homoeopathic Medical College & Hospital  Dept of Repertory, OPD room no. PG3, Surgery (5), Medicine (1), 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL 		 9080395909

raguram9497@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee of D. N. De Homoeopathic Medical College & Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M659||Synovitis and tenosynovitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical- looking placebos  This arm will receive placebo, identical in appearance from verum. Each dose of placebo shall consist of 4 globules (no. 40) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Route of administration: Per oral; duration of therapy: 6 months 
Intervention  Individualized homoeopathic medicines in centesimal potencies  Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Route of administration: Per oral; duration of therapy: 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with wrist ganglion (ICD-11 Code FB42.2) clinically and by USG.
2. Age 18- 65 years
3. Participants of either sex or transgender
4. Participants having prior experience or knowledge of the treatment. e.g. primed to expect homoeopathic aggravation and available treatment options for the disease conditions, intimated through Patient Information Sheet 
 
ExclusionCriteria 
Details  1. Not providing written informed consent of participation.
2. Non-ambulant patients.
3. Patient suffering from active or chronic, systemic or local infection or disease.
4. Patients who are too sick for consultation.
5. Unwilling to take part and not giving consent to join the study
6. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life.
7. Pregnancy, puerperal women and lactating mother.
8. Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool) [21].
9. Self-reported immune-compromised state, AIDS, hepatitis etc.
10. Undergoing homoeopathic treatment for any chronic disease within last 6 months.
11. 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 
The size (diameter and height) of the lesion, measured with slide calipers  Baseline, every month, up to 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
PRWE- Patient-Rated Wrist Evaluation   Baseline, every month, up to 6 months 
MWS- Mayo Wrist Score   Baseline, every month, up to 6 months 
MYMOP-2- Measure Yourself Medical Outcome Profile  Baseline, every month, up to 6 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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/ Phase 3 
Date of First Enrollment (India)   01/04/2024 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [raguram9497@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary   Ganglion is a nodular tumor - like lesions or mucoid flesh, arising from tendon sheaths,  ligaments, or joint capsule, especially of the hands, wrists, or feet. They are not true cysts as  they lack epithelial wall. Dorsal wrist ganglion symptoms include discomfort, weakness, difficulty doing daily tasks, or a growth in size, patients typically seek medical attention etc., though the use of homoeopathic medicines is  extensive globally to treat dorsal wrist ganglion, diligent research evidence in favour of homoeopathic is not well marked. So we intend to undertake the research to evaluate the efficacy and safety of homoeopathic medicines in the treatment of dorsal wrist ganglion. Thus, this double- blind , randomized (2:1), placebo – controlled, trail, using individualized homoeopathic medicines along with  standard care will be conducted on 36 suffering from dorsal wrist ganglion in both the outpatient and inpatient departments of  D. N. De homoeopathic medical collage & hospital. Primary outcome will be  the changes in the size of the lesion of ganglion using digital slide calipers . Patient-Rated Wrist Evaluation( PRWS), Mayo Wrist Score( MWS), Measure Yourself Medical Outcome Profile (MYMOP - 2) will be the secondary outcome. All the outcome will be measured every month up to 6 months. Group differences will be analyzed statistically . Results will be published in scientific journal. 
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