| CTRI Number |
CTRI/2025/04/084661 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Role of Homoeopathic Medicine in management of Myopia. |
|
Scientific Title of Study
|
An Exploratory Study To Assess The Role Of Homeopathic Medicines On Myopia Between Age Group Of 18-30 Years |
| 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 Hina R Patel |
| Designation |
Ph D Scholar Principal |
| Affiliation |
Vidhyadeep Homoeopathic Medical College and research centre |
| Address |
Room no 4 Homoeopathy Department Vidhyadeep Homoeopathic Medical College and Research Centre
Vidhyadeep University
Anita
kim
Surat 394110 Room no 4 Homoeopathy Department Vidhyadeep Homoeopathic Medical College and Research Centre
Vidhyadeep University
Anita
kim
Surat 394110 Surat GUJARAT 394110 India |
| Phone |
9106371752 |
| Fax |
|
| Email |
hinarpatel77@yahoo.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hina R Patel |
| Designation |
Ph D Scholar Principal |
| Affiliation |
Vidhyadeep Homoeopathic Medical College and research centre |
| Address |
Room no 4 Homoeopathy Department Vidhyadeep Homoeopathic Medical College and Research Centre
Vidhyadeep University
Anita
kim
Surat 394110 Room no 4 Homoeopathy Department Vidhyadeep Homoeopathic Medical College and Research Centre
Vidhyadeep University
Anita
kim
Surat 394110 Surat GUJARAT 394110 India |
| Phone |
9106371752 |
| Fax |
|
| Email |
hinarpatel77@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Vipul R Shastri |
| Designation |
Principal of VHMC and RC I/C Provost of Vidhyadeep University Guide |
| Affiliation |
Vidhyadeep Homoeopathic Medical College and research centre |
| Address |
Room no 4 Homoeopathy Department Vidhyadeep Homoeopathic Medical College and Research Centre Vidhyadeep University
Anita
kim
Surat Surat GUJARAT 394110 India |
| Phone |
9824109174 |
| Fax |
|
| Email |
drvipulshastri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhargava Homoeopathic Medical College and Bhargava Homoeopathic and General Hospital R H Patel Technical Campus At Vidhyagram At & Po Dahemi Ta Borsad Gujarat 388350 India |
|
|
Primary Sponsor
|
| Name |
Vidhyadeep Homoeopathic Medical College and Research Centre |
| Address |
Vidhyadeep Homoeopathic Medical College and Research Centre
Vidhyadeep University |
| Type of Sponsor |
Private medical college |
|
|
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 Hina R Patel |
Vidhyadeep Homoeopathic medical college and research centre |
Room no 4
Vidhyadeep Homoeopathic medical college and research centre
Vidhyadeep University
Anita
Kim
surat
394110 Surat GUJARAT |
9106371752
hinarpatel77@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vidhyadeep Institutional Ethical Committee |
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 |
| Intervention |
Homeopathic Medicines for Myopia |
Participants with myopia will receive homeopathic medicines based on their symptoms. They will take 4-5 globules sublingually in potencies of 6, 30, 200, and 1M, twice daily. Each remedy will be given for 15 days, with changes made as needed during follow-ups. Follow-ups will be done every 15 days to track progress. Myopia will be measured in diopters (D) using an Auto Refractor Meter. The first measurement will be taken at the start, followed by monthly check-ups. The final result will be assessed after three months by comparing changes from the baseline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients of walk in clinic who are pre diagnosed with Myopia would be selected for the case.
Case studies would depend on the progression treatment would be decided.
The visual appearance of the changes in the eye of the patient would be identified.
|
|
| ExclusionCriteria |
| Details |
Cases having advanced pathological findings will not be included in the study
Cases not wanting to try homoeopathy with other medicines would also be excluded.
Cases with operations of laser and lenses are also excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the change in the degree of myopia, measured in diopters (D) using an Auto Refractor Meter. The refractive error will be compared with baseline values to assess the impact of individualized homeopathic treatment on the progression of myopia |
Baseline and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the role of only homoeopathy in curing disorders related to Myopia in eyes |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
25/04/2025 |
| 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 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
|
Myopia is very common problem prevalent worldwide as well as in India. It is one of the leading cause for the visual impairment. It is a primary visual blindness. It has been confirmed after the detail examination of eye with correct glasses. Homoeopathic medicines acts well in cases of myopia. In order to see the utility of homoeopathic medicines in myopia this study is taken up. |