| CTRI Number |
CTRI/2023/03/051207 [Registered on: 31/03/2023] Trial Registered Prospectively |
| Last Modified On: |
30/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Myopia-Prevalence and management |
|
Scientific Title of Study
|
Myopia -Prevalence and management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreeja Sukesan |
| Designation |
Professor and HOD, Dept of Salakyatantra |
| Affiliation |
Govt Ayurveda College Tripunithura |
| Address |
Govt Ayurveda College
Dhanwanthari Nagar
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
7034115701 |
| Fax |
|
| Email |
doctorsreejamd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreeja Sukesan |
| Designation |
Professor and HOD, Dept of Salakyatantra |
| Affiliation |
Principal Investigator of project, Institution-Govt Ayurveda College Tripunithura |
| Address |
Department of Salakyatantra
Govt Ayurveda College
Dhanwanthari Nagar
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
7034115701 |
| Fax |
|
| Email |
doctorsreejamd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreeja Sukesan |
| Designation |
Professor and HOD, Dept of Salakyatantra |
| Affiliation |
Govt Ayurveda College Tripunithura |
| Address |
Department of Salakyatantra
Govt Ayurveda College
Dhanwanthari Nagar
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
7034115701 |
| Fax |
|
| Email |
doctorsreejamd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of Kerala
Directorate of Ayurveda Medical Education
Pulimoodu, Thiruvananthapuram-696001
|
|
|
Primary Sponsor
|
| Name |
Govt of Kerala |
| Address |
Directorate of Ayurveda Medical Education
Santhi Nagar
Pulimoodu
Thiruvananthapuram 696001
|
| Type of Sponsor |
Government funding agency |
|
|
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 Sreeja Sukesan |
Govt Ayurveda College Tripunithura |
Op No 4
Department of Salakyatantra
Govt Ayurveda College
Dhanwanthari Nagar
Tripunithura-682301
Govt Ayurveda College
Dhanwanthari Nagar
Tripunithura -682301
Ernakulam
KERALA |
7034115701
doctorsreejamd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional commitee of ethics for research in ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H538||Other visual disturbances. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sekaH, सेकः | (Procedure Reference: Susrutha Samhita Utharasthana 18/2 , Procedure details: Powdered yashti and lodhra,5 g each, are boiled in 8 glass of water and reduced to 2 glass and cooled and filtered and poured over closed eyelid for 5 minutes slowly and continuously )
(1) Medicine Name: Yashti lodhra kashaya , Reference: Ashtangs Hridaya Utharasthana 19/32, Route: Ocular, Dosage Form: Kwatha/Kashaya, Dose: 10(g), Frequency: bd, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Students with low myopia<-1D studying in Std I-XII |
|
| ExclusionCriteria |
| Details |
Students with other systemic illness and who are non- co-operative with vision test |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Distant vision |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Headache, pain around eyes, styles, watering |
4 months |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Back ground-Myopia is the most common refractive error in school going children and young adults and estimates suggest that 50% of population will become myopic by 2050 Purpose-To study the prevalence of high myopia and to study the effect of ayurvedic management in low myopia<-1D
Myopia patients less than 1 D will be given agni correction, sekam with yashti lodhra kashayam and agni correction for 3 months and evaluated |