| CTRI Number |
CTRI/2026/01/100341 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homoeopathy in the treatment of Progressive Myopia in children |
|
Scientific Title of Study
|
Comparative Efficacy of Individualized Homoeopathic Medicines, Ruta Graveolans 30C and Physostigma 6C in Progressive Myopia in children: A single blind, randomized comparative 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 Divya Taneja |
| Designation |
Research Officer/ Scientist 3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no. 304, Central Council for Research in Homoeopathy, 61-65 Institutional area, Opposite D Block, Janakpuri, New Delhi
South West DELHI 110058 India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer/ Scientist 3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no. 304, Central Council for Research in Homoeopathy, 61-65 Institutional area, Opposite D Block, Janakpuri, New Delhi
South West DELHI 110058 India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Renu Mittal |
| Designation |
Research Officer/ Scientist 4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no. 304, Central Council for Research in Homoeopathy, 61-65 Institutional area, Opposite D Block, Janakpuri, New Delhi
South West DELHI 110058 India |
| Phone |
9717511115 |
| Fax |
|
| Email |
renumittal8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65 Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, Institutional Area, Opp. D-Block, Janakpuri, New Delhi- 110058, India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, 61-65, Institutional Area, Opp. D-Block, Janakpuri, New Delhi- 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Prashant Tamboli |
Dr M L Dhawale Memorial Trust Hospital |
Room No 112, 113, Opthalmology Department, Palghar, Maharashtra, India- 401404 Palghar MAHARASHTRA |
9322283197
drtamboli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr M L Dhawale Memorial Homoeopathic Institute, IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualized homoeopathy |
As per presenting signs & symptoms, Posology will be as per principles of Homoeopathy. Medicines in compliance with pharmacopoeial standards from GMP compliant manufacturers would only be used. |
| Intervention |
Physostigma 6C |
Four globules twice a day for the total duration of 1 year. Medicines in compliance with pharmacopoeial standards from GMP compliant manufacturers would only be used. |
| Intervention |
Ruta 30C |
Four globules twice a day for the total duration of 1 year. Medicines in compliance with pharmacopoeial standards from GMP compliant manufacturers would only be used. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Refractive error of between minus 1 diopters to minus 5 diopters without glasses
Minimum spherical equivalent (SE) to be minus 1 D (SE= sphere+1/2 cylinder) |
|
| ExclusionCriteria |
| Details |
Myopia related to retinal dystrophies or collagen syndromes, and developmental disorders.
Children suffering from illness like Autism, Intellectual Disability, Attention Deficit Hyperactive Disorder, Congenital Cataract, Retinal detachment or Myopic macular degeneration. Children suffering from Malnutrition which will be defined as Standard deviation of less than 1 of basic metabolic index according to Z score Rashtriya Bal Swasthya Karyakaram chart for BMI chart for age 6 to 18 years (Z sccore).
Participants unable to come for regular fortnightly follow up
Legally authorized representative (LAR) are unable to give consent for the homoeopathic treatment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Annual myopic progression rate |
Baseline, end of 3 months, 6 months, 9 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Axial length (AL) |
Baseline and end of 12 months |
| Curvature changes |
Baseline and end of 12 months |
| Annual axial length progression rate |
Baseline and end of 12 months |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
01/02/2026 |
| 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="2" 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 - NO
|
|
Brief Summary
|
The study titled ’Comparative Efficacy of Individualized Homoeopathic Medicines, Ruta Graveolans 30C and Physostigma 6C in progressive Myopia in children is a single blind, randomized, comparative trial with the primary objective to assess changes in the progression rate of vision acuity in children with myopia and secondary objective is to assess changes in the progression rate of vision acuity in children with myopia. The duration of the study will be 2 years wherein duration of participation and intervention in the study shall be one year for individual participants. Participants of age 6- <10 years, both sexes with Refractive error of -1.00 D to -5.0 D without glasses and Minimum spherical equivalent (SE) -(minus)1D. (SE=sphere+1/2 cylinder) will be included in the study. Myopia related to retinal dystrophies or collagen syndromes, and developmental disorders, children suffering from illness like autism, intellectual diasbilities, ADHD, Congenital cataract, retinal detachment or myopic macular degeneration, children suffering from malnutrition which will be defined as standard deviation of < -1 SD of basic metabolic index according to Rastriye bal swasthya karyakaram chart for BMI chart for age 6 to 18 years (Z score), participants unable to come for regular fortnightly follow up and legally authorized reperesentative is unable to give consent for the homoeopathic treatment will be excluded. The primary outcome measure includes annual myopic progression rate to be assessed at baseline and every 3 months for 1 year by snellen chart. the secondary outcome measures include axial length, curvature changes and annual axial length progression rate to be assessed at baseline and 12 months after initiation of treatment.
|