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CTRI Number  CTRI/2025/09/094985 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   STUDYING THE POTENTIAL OF HOMEOPATHY AS AN ADJUVANT THERAPY TO STANDARD TREATMENT FOR NON-PROLIFERATIVE DIABETIC RETINOPATHY 
Scientific Title of Study   EVALUATING THE EFFICACY OF INDIVIDUALISED TREATMENT IN HOMOEOPATHY AS AN ADJUVANT THERAPY TO STANDARD MEDICAL CARE IN THE MANAGEMENT OF NON-PROLIFERATIVE DIABETIC RETINOPATHY: A SINGLE BLIND, 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 Samanvitha T 
Designation  PG Scholar 
Affiliation  BHARATI VIDYAPEETH (Deemed to be University) HOMOEOPATHIC MEDICAL COLLEGE & HOMOEOPATHIC HOSPITAL 
Address  BHARATI VIDYAPEETH (Deemed to be University) HOMOEOPATHIC MEDICAL COLLEGE & HOMOEOPATHIC HOSPITAL,DEPT. OF POST-GRADUATE & RESEARCH CENTRE,Dhankawadi, Pune-Satara Road, Pune - 411043

Pune
MAHARASHTRA
411043
India 
Phone  9902609905  
Fax    
Email  samanvitha.t-hmcpune@bvp.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Snehalkumar Harne 
Designation  Assistant Professor 
Affiliation  BHARATI VIDYAPEETH (Deemed to be University) HOMOEOPATHIC MEDICAL COLLEGE & HOMOEOPATHIC HOSPITAL 
Address  BHARATI VIDYAPEETH (Deemed to be University) HOMOEOPATHIC MEDICAL COLLEGE & HOMOEOPATHIC HOSPITAL,DEPT. OF POST-GRADUATE & RESEARCH CENTRE,Dhankawadi, Pune-Satara Road, Pune - 411043

Pune
MAHARASHTRA
411043
India 
Phone  9890564928  
Fax    
Email  snehalkumar.harne@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Snehalkumar Harne 
Designation  Assistant Professor 
Affiliation  BHARATI VIDYAPEETH (Deemed to be University) HOMOEOPATHIC MEDICAL COLLEGE & HOMOEOPATHIC HOSPITAL 
Address  BHARATI VIDYAPEETH (Deemed to be University) HOMOEOPATHIC MEDICAL COLLEGE & HOMOEOPATHIC HOSPITAL,DEPT. OF POST-GRADUATE & RESEARCH CENTRE,Dhankawadi, Pune-Satara Road, Pune - 411043

Pune
MAHARASHTRA
411043
India 
Phone  9890564928  
Fax    
Email  snehalkumar.harne@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
BHARATI VIDYAPEETH (Deemed to be University)HOMOEOPATHIC MEDICAL COLLEGE & HOMOEOPATHIC HOSPITAL, DEPT. OF POST-GRADUATE & RESEARCH CENTRE, Dhankawadi, Pune-Satara Road, Pune -411043  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Samanvitha T  BHARATI VIDYAPEETH (Deemed to be University) HOMOEOPATHIC MEDICAL COLLEGE & HOMOEOPATHIC HOSPITAL  DEPT. OF POST-GRADUATE & RESEARCH CENTRE, Dhankawadi, Pune-Satara Road, Pune - 411043 MAHARASHTRA
Pune
MAHARASHTRA 
9902609905

samanvitha.t-hmcpune@bvp.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY) HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, PUNE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic treatment  along with standard medical care, Individualized Homoeopathy remedy prescribed according to classical homeopathic principles after comprehensive case-taking, repertorization with synthesis repertory and verified with Materia medica. Potency is selected on the basis of susceptibility and medicine is prescribed orally, one packet powder dose stat and pills twice a day. 
Comparator Agent  Placebo group  subjects will be kept only on standard medical cared while placebo is given in the form of unmedicated sac lac powder 1 dose and unmedicated pills twice a day 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Clinically confirmed Non proliferative diabetic retinopathy (mild to moderate severity)
Currently receiving standard medical care for diabetes and Non proliferative diabetic retinopathy
Willingness to participate with written consent
 
 
ExclusionCriteria 
Details  Proliferative diabetic retinopathy
HbA1c more than 10.0 percent
Hypertensive retinopathy
Cases needing surgical intervention
Recent (less than 6 months) ocular surgery
Pregnancy or planned pregnancy during study period
Current participation in other clinical trial
Significant hepatic impairment having more than and including Class B child phug score
Angle closure glaucoma
Renal impairment with GFR less than 59 ml per min per 1.73m3
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Retinal microvasculature as measured by Retinal fundoscopy and assessed using ICDR scale  6 months with monthly follow ups 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in Vision-related quality of life (NEI-VFQ-25)  6 months with monthly follow ups 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   30/09/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [samanvitha.t-hmcpune@bvp.edu.in].

  6. For how long will this data be available start date provided 22-09-2025 and end date provided 22-03-2027?
    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 - NIL
Brief Summary
Modification(s)  

Diabetic retinopathy (DR) represents a significant global health challenge, especially given the rising prevalence of diabetes mellitus worldwide. In recent years, there have been remarkable strides in the diagnosis, technological advancements, and treatment options for DR, which have significantly changed the way we approach and manage the condition. Key developments such as the widespread availability of optical coherence tomography (OCT) for imaging, as well as the introduction of anti-vascular endothelial growth factor (VEGF) therapies, have dramatically improved both the early detection and treatment of DR. These advancements have paved the way for better outcomes for patients. However, the field continues to evolve, with ongoing research and innovations offering promising new solutions for further improving the management and treatment of diabetic retinopathy. Homoeopathy has the potential to treat various ophthalmic conditions quickly, effectively, and safely, with minimal risk of recurrence.

AIM: to test the efficacy of individualized treatment in homoeopathy as an adjuvant therapy to standard medical care in the management of non-proliferative diabetic retinopathy.

MATERIALS AND METHODS: A prospective, single blind, randomized controlled trial with a 6-month follow-up period, will be conducted at BHARATI VIDYAPEETH  (Deemed to be University) HOMOEOPATHIC MEDICAL COLLEGE & HOMOEOPATHIC HOSPITAL OPD, Pune. Thirty participants fulfilling the inclusion criteria will be randomized into 2 groups- group A will receive Individualized homoeopathic treatment along with standard medical care while group B will receive placebo .The cases will be analyzed and evaluated for the condition over a duration of 6 months with monthly follow ups. The ophthalmologist and homoeopathic expert will follow up concurrently. Frequency for fundoscopy follow up will be determined by ophthalmologist on basis of symptoms of the patient. At the end of the study, the patient is again evaluated on the parameters of baseline assessment and the results are concluded after the analysis with appropriate statistical tools.

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