| CTRI Number |
CTRI/2025/06/089482 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
The use of homoeopathic medicine as an adjuvant to conventional therapy in managing diabetic retinopathy |
|
Scientific Title of Study
|
The effect of homoeopathic medicine as an adjuvant to conventional medicine in the management of diabetic retinopathy:A comparative clinical trial |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kadeeja Jessy P A |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government homoeopathic medical college |
| Address |
Department of Practice of medicine
Government homoeopathic medical college karaparamba kozhikode 673010
Government homoeopathic medical college karaparamba kozhikode 673010
Kozhikode
KERALA
673010
India |
| Phone |
09946497973 |
| Fax |
|
| Email |
jescurio2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Hameed |
| Designation |
Guide |
| Affiliation |
Government homoeopathic medical college |
| Address |
Department of Practice of medicine
Government homoeopathic medical college karaparamba kozhikode 673010
Government homoeopathic medical college karaparamba kozhikode 673010
Kozhikode
KERALA
673010
India |
| Phone |
9447632227 |
| Fax |
|
| Email |
hameeddr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kadeeja Jessy P A |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government homoeopathic medical college |
| Address |
Department of Practice of medicine
Government homoeopathic medical college karaparamba kozhikode 673010
Government homoeopathic medical college karaparamba kozhikode 673010
Kozhikode
KERALA
673010
India |
| Phone |
09946497973 |
| Fax |
|
| Email |
jescurio2000@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Kadeeja Jessy P A |
| Address |
Post Graduate Scholar
Department of Practice of medicine
Government homoeopathic medical college karaparamba kozhikode 673010
Government homoeopathic medical college kozhikode |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kadeeja Jessy P A |
Government homoeopathic medical college |
Government homeopathic medical college kozhikode
Kozhikode
KERALA |
09946497973
jescurio2000@gmail.com |
| Lizmy |
Malabar Eye Hospital |
Room No 22 Eranjipalam
Kozhikode
KERALA |
9447551747
lizmyajith@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Homoeopathic Medical College Kozhikode Kerala |
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 |
Individualised Homoeopathic medicine |
Individualised homoeopathic medicine is given to group A. The medicine prescription ,potency ,dose based on homoeopathic principle . medicine is given for 6 months |
| Comparator Agent |
Conventional medicine |
Conventional medicine is given to group B who receive treatment at Malabar Eye Hospital for 6 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients with fasting blood sugar level (FBS) more than 150 mg dl and postpartum blood sugar (PPBS)more than 200mg dl
All patients with diabetic retinopathy diagnosed by fundoscopic photographs
Patients belonging to age above 30 years
Patients satisfying the working case definition
Patients belonging to both sexes |
|
| ExclusionCriteria |
| Details |
Cases with other retinopathies like hypertensive retinopathy.
Cases of highly advanced diabetic retinopathy (ETDRS level above 80).
Cases with systemic illness including malignancies and diagnosed Neurological disease.
Cases with Psychiatric comorbidities. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement of diabetic retinopathy by visual acuity by Snellen chart |
follow up will be taken at 6 months duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of diabetic retinopathy by visual acuity by ETDRS DRSS |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/07/2025 |
| 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="0"
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
Modification(s)
|
Study consists of two groups to which first group receiving homoeopathic medicine and second group receiving conventional medicine and outcome will be compared after a year |