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CTRI Number  CTRI/2025/11/097273 [Registered on: 12/11/2025] Trial Registered Prospectively
Last Modified On: 12/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Cineraria maritima eye drops in the prevention of progression of immature cataract 
Scientific Title of Study   Anti-cataract Effects Of Cineraria maritima Eye Drops In The Progression Of Immature Cataract: A Pilot Open-label Prospective Observational Study 
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 Renu Mittal  
Designation  Research Officer (Homoeopathy) Scientist 4  
Affiliation  Central Council for Research in Homoeopathy  
Address  Room no. 304, Central Council for Research in Homoeopathy, Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block Janakpuri

South West
DELHI
110058
India 
Phone  9717511115  
Fax    
Email  renumittal8@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Renu Mittal  
Designation  Research Officer (Homoeopathy) Scientist 4  
Affiliation  Central Council for Research in Homoeopathy  
Address  Room no. 304, Central Council for Research in Homoeopathy, Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block Janakpuri

South West
DELHI
110058
India 
Phone  9717511115  
Fax    
Email  renumittal8@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Divya Taneja  
Designation  Research Officer (Homoeopathy) Scientist 3  
Affiliation  Central Council for Research in Homoeopathy  
Address  Room no 309, Central Council for Research in Homoeopathy, Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block Janakpuri

South West
DELHI
110058
India 
Phone  9810305068  
Fax    
Email  drdivyataneja@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, Opposite D Block, Janak Puri, 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, Opposite D Block Janakpuri  
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, Ophthalmology Department, Palghar Boisar Road
Palghar
MAHARASHTRA 
9322283197

drtamboli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CENTRAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H269||Unspecified cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cineraria maritima eye drops (without alcohol)  Cineraria maritima eye drops (without alcohol), in compliance with pharmacopoeial standards procured from GMP compliant pharmaceutical firm, twice a day will be used for one year and 6 months. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients between 40 to 80 years of age
Gender: both
Visual acuity better than or equal to 6/60 Snellen’s chart
Patients who meet the diagnostic standards of immature cataract using slit lamp Biomicroscopic examination.
 
 
ExclusionCriteria 
Details  Patients suffering from congenital Cataract, mature and hypermature Cataract, Glaucoma, Diabetic Retinopathy, Hypertensive retinopathy, Macular degeneration, Retinitis pigmentosa
Patients with uncontrolled blood sugar and blood pressure
Patients who are under steroid treatment or Immunosuppressive therapy or any cataract-inducing medications
Unwilling to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. Change in symptoms & signs– blurring of vision,visualization of non-existing things, nyctalopia, hemeralopia, glare, intra-ocular pressure, unaided distant visual acuity, pin hole vision, best corrected distant visual acuity using grading pattern by Snellen’s chart and Jaeger’s chart reading
2. Change in grading of cataractous lens, according to lenticular opacity classification system III to assess changes in the area and density of lenticular opacity by slit lamp biomicroscopic examination, in tangentional sectioning and retro illumination technique 
1. Baseline, end of 3rd month, 6th month, 9th month, 12th month, 15th month & 18th month
2. Baseline, end of 6th month, 12th month & 18th month 
 
Secondary Outcome  
Outcome  TimePoints 
Change in visual score & quality of life to be assessed by VFQ-25  baseline, end of 3rd month, 6th month, 9th month, 12th month, 15th month & 18th month 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   01/12/2025 
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="2"
Months="6"
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  

A study titled "ANTI-CATARACT EFFECTS OF CINERARIA MARITIMA EYE DROPS IN THE PROGRESSION OF IMMATURE CATARACT: A PILOT OPEN-LABEL PROSPECTIVE OBSERVATIONAL STUDY" is a Pilot Open-Label Prospective Observational Study of  2 years and 6 months duration with a Primary Objective to evaluate the effects of Cineraria maritima eye drops on the signs & symptoms of cataract, in the improvement of visual acuity using Snellen’s chart and Jaeger’s chart reading and to evaluate the change in grading of cataract using Slit lamp Biomicroscopic examination. Secondary Objective is to evaluate the anti-cataract effects of Cineraria maritima eye drops on visual scores & quality of life based on VFQ-25. Patients between 40 to 80 years of age, both gender, visual acuity better than or equal to 6/60 Snellen chart, and patients who meet the diagnostic standards of immature cataract using slit lamp Biomicroscopic examination will be included in study. Patients suffering from congenital Cataract, mature and hypermature Cataract, Glaucoma, Diabetic Retinopathy, Hypertensive retinopathy, Macular degeneration, Retinitis pigmentosa, Patients with uncontrolled blood sugar and blood pressure, Patients who are under steroid treatment or Immunosuppressive therapy or any Cataract inducing medications, patients unwilling to participate in the study will be excluded from the study.  Primary outcome will be change in symptoms & signs– blurring of vision, visualization of non-existing things, nyctalopia, hemeralopia, glare, intra-ocular pressure, unaided distant visual acuity, pin hole vision, best corrected distant visual acuity using grading pattern on quarterly basis by Snellen’s chart and Jaeger’s chart reading  at baseline and at every quarterly follow up & change in Grading of cataractous lens,, according to lenticular opacity classification system III to assess changes in the area and density of lenticular opacity by Slit lamp Biomicroscopic examination, in tangentional sectioning and retro illumination technique at baseline, 6th month, 12th month and at the end of treatment (18th month) & Secondary outcome will be Change in visual score & quality of life to be assessed by VFQ-25 at baseline and at every quarterly follow up and at the end of treatment (18th month).

 
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