| CTRI Number |
CTRI/2024/03/064704 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to find how homeopathic medicines help with nearsightedness (myopia) |
|
Scientific Title of Study
|
Clinical study to evaluate the effectiveness of Physostigma venenosum 6c, Eserinum 6c and homoeopathic ‘constitutional remedies’ in developmental myopia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Antony Rozario J |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka mission’s homoeopathic medical college and hospital, VMRF-DU, Salem |
| Address |
Vinayaka mission’s homoeopathic medical college and hospital, Chinna seeragapadi, Sankari main road(NH-47), Ariyanoor
Salem
TAMIL NADU
636308
India |
| Phone |
9894431131 |
| Fax |
|
| Email |
rozee1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANTONY ROZARIO J |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka mission’s homoeopathic medical college and hospital, VMRF-DU, Salem |
| Address |
Vinayaka mission’s homoeopathic medical college and hospital, Chinna seeragapadi, Sankari main road(NH-47), Ariyanoor
Salem
TAMIL NADU
636308
India |
| Phone |
9894431131 |
| Fax |
|
| Email |
rozee1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Rathnasabapathi |
| Designation |
Professor Hod of Dept of paediatrics |
| Affiliation |
Vinayaka mission’s homoeopathic medical college and hospital, VMRF-DU, Salem |
| Address |
HOD, Department of Paediatrics, Vinayaka mission’s homoeopathic medical college and hospital, Chinna seeragapadi, Sankari main road(NH-47), Ariyanoor
Salem
TAMIL NADU
636308
India |
| Phone |
9842765594 |
| Fax |
|
| Email |
drersaba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road
Seeragapadi PO Salem TAMILNADU 636308 India |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
NH 47 Sankari Main Road Seeragapadi PO Salem TAMIL NADU
636308 India |
| 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 |
| ANTONY ROZARIO J |
Vinayaka mission’s homoeopathic medical college and hospital |
M-I Unit, Room number 1A,
Department of Organon,
Ground Floor,
Hospital Block,
Vinayaka missions
homoeopathic medical
college and hospital,
NH-47, Sankari Main
Road, Chinnaseeragapadi, Ariyanoor
Salem
TAMIL NADU |
9894431131
rozee1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Vinayaka Missions Kirupananda Variyar Medical College And Hospital Salem |
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 |
Control group |
Corrective spectacles.​
|
| Intervention |
Medicinal Group |
1.Physostigma 6C Group
2.Eserinum 6C Group
3.Homoeopathic Constitutional remedies |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Participants with varying degrees of myopia more than​
-0.5D, with a specified age range 19 years to 45 years, will be included.​
Moderate to High myopic children in ages ranging 7 to 11 years.​
Moderate to low myopic children in ages ranging 7 to 11 with parental myopic history are included.​
Bilateral or unilateral myopia (ICD11-9D00.0) associated with astigmatism, blurred vision, headache or eye strain are included.​ |
|
| ExclusionCriteria |
| Details |
Anyone who is already under homoeopathic treatment.​
Anyone who has undergone recent myopia-related treatment (use of ophthalmic solutions or surgical measures).​
Congenital conditions (ICD11-LD27.Y, LA14.0Y, LA12.Y, 9B70)​
Degenerative myopia (ICD11-9B76)​
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
All three medicines were effective in slowing down myopia progression, also reduction in diopters is noted along with reduction in the intensity of the associated symptoms.​
​
Progression of myopia was better in the constitutional medicine group.​
​
No remission of myopia or associated symptoms post treatment with constitutional medicine.​ |
Ophthalmic assessment done once in three months until one year and followed up for six more months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Establishing anti myopic activity of specific drugs |
Every three months after the beginning of treatment protocol ophthalmic assessment is done for one year, i.e., four assessments for each patient |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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 4 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 complications caused by myopia is more
than the complications of eye conditions caused by diabetes.​Homoeopathy has registered success records in
treating various ophthalmic conditions.​ Homoeopathy offers simple solutions as an alternative to the intricate
daily routines, expensive and invasive procedures which are usually suggested
to reduce the progression of myopia. The increasing problem of myopia can be
tackled well with proper use of Homoeopathic medicines.​Previous studies has been conducted with Ruta
grav., Physostigma vene., constitutional medicines from BBCR repertory. ​Current study aims to see the effectiveness
of Phys ven. 6C, Eser. 6C and Constitutional remedy with a control group.
|