| 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
|
|
|
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
|
|
|
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
- 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 - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [samanvitha.t-hmcpune@bvp.edu.in].
- 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.
- 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. T |