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CTRI Number  CTRI/2026/01/101901 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the efficacy of homoeopathy in management of rheumatoid arthritis 
Scientific Title of Study   A comparative study to assess the effectiveness of individualised homoeopathic medicines with standard line of treatment in the improvement of disease activity score in management of rheumatoid arthritis: a randomized controlled trial 
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 Preeti Lamba 
Designation  Associate Professor Department of Homoeopathic Materia Medica. 
Affiliation  Dr D Y Patil Homoeopathic Medical College and Research Centre Pimpri Pune 
Address  Department of Homoeopathic Materia Medica, Ground Floor, room no 2 Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9011076454  
Fax    
Email  preeti.lamba@dpu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Dharmendra Sharma 
Designation  Principal and Guide 
Affiliation  Dr D Y Patil Homoeopathic Medical College and Research Centre Pimpri Pune 
Address  Ground Floor, room- Principal Cabin Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9422330045  
Fax    
Email  principal.homoeopathy@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Preeti Lamba 
Designation  Associate Professor Department of Homoeopathic Materia Medica 
Affiliation  Dr D Y Patil Homoeopathic Medical College and Research Centre Pimpri Pune 
Address  Department of Homoeopathic Materia Medica, Ground floor, room no 2 Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9011076454  
Fax    
Email  preeti.lamba@dpu.edu.in  
 
Source of Monetary or Material Support  
Infrastructure of OPD and IPD of hospital of Dr D Y Patil Homoeopathic Medical College and Research Centre Pimpri Pune will be utilised for the study. As mentioned in the site, patients of OPD and IPD of the same hospital will also be part of the study. 
Infrastructure of OPD and IPD of hospital of Dr D Y Patil Medical College hospital and Research Centre Pimpri Pune will be utilised for the study. As mentioned in the site, patients of OPD and IPD of the same hospital will also be part of the study. 
 
Primary Sponsor  
Name  Dr Preeti Lamba 
Address  Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune 411018 
Type of Sponsor  Other [It is self sponsored project with no external funding] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preeti Lamba  Dr D Y Patil Medical College Hospital and Research Centre  Ground Floor, D Y Patil Hospital OPD and IPD Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA 		 9011076454

preeti.lamba@dpu.edu.in 
Dr Preeti Lamba  Dr D Y Patil Homoeopathic Medical College and Research Centre  1st Floor, Homoeopathic Hospital OPD and IPD Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA 		 9011076454

preeti.lamba@dpu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr D Y Patil Homoeopathic Medical College and Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised Homoeopathic Medicines  Individualised Homoeopathic Medicines will be administered to 100 Patients (Group A) of Rheumatoid Arthritis as intervention and effect will be compared with the comparator which is Standard line of treatment  
Comparator Agent  Standard line of treatment  Standard line of treatment will be administered to another 100 Patients (Group B) of Rheumatoid Arthritis and effect will be compared against that of intervention which are Individualised Homoeopathic Medicines 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Participants must be diagnosed with rheumatoid arthritis according to recognised diagnostic standards set by American College of Rheumatology/European League Against Rheumatism
Both male and female
2. Age 30 to 50 years
3. Disease Activity Score 28 between 2.6 to 5.1 
 
ExclusionCriteria 
Details  1. Age less than 30 and above 50 years
2. Disease Activity Score 28 less than 2.6 and more than 5.1
3. Any bone deformity
4. Pregnant or lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the extent of reduction in joint pain, swelling and stiffness measured by the Disease Activity Score (DAS28) in Rheumatoid Arthritis patients   Every three months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess improvement in health-related quality of life measured by the Health Assessment Questionnaire in Rheumatoid Arthritis patients   Every three months 
To measure the improvement or changes if any in necessary investigations performed at the beginning and end of study especially C- Reactive Protein (CRP) & Erythrocyte Sedimentation Rate (ESR)  Every three months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 3 
Date of First Enrollment (India)   15/02/2026 
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="3"
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 - 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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 [preeti.lamba@dpu.edu.in].

  6. For how long will this data be available start date provided 15-12-2025 and end date provided 14-12-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Rheumatoid arthritis (RA) can make daily living difficult since it limits mobility and damages joints. RA reduces a person’s quality of life since it incapacitates them. There is no known treatment for RA, although there are medications that may be able to control symptoms and slow the disease’s progression. Previous research has suggested that homoeopathy may improve patient outcomes in chronic diseases, but rigorous clinical trials comparing its efficacy to standard treatment in RA are missing. This research may also lessen the dependence on larger doses of traditional medications, hence minimizing associated negative effects. 
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