| 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
|
|
|
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
|
|
|
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). |