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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  
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 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  
Status 
Not Applicable 
 
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.


 
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