| CTRI Number |
CTRI/2013/05/003614 [Registered on: 06/05/2013] Trial Registered Retrospectively |
| Last Modified On: |
02/05/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A observational study to evaluate the efficacy and safety of Ayurvedic treatment in eyes affected by Progressive Myopia |
|
Scientific Title of Study
|
A Single Centric, Observational Trial To Assess The Efficacy Of Ayurvedic Therapy In Management of Progressive Myopia in The Age Group of 5 to 18 years. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NPP NAMBOOTHIRI |
| Designation |
Managing Director and Chief Physician |
| Affiliation |
Sreedhareeyam Ayurvedic Eye Hospital and Research Centre |
| Address |
Nelliakkattu Mana
Kizhakombu Post Office
Koothattukulam
Ernakulam
KERALA
686662
India |
| Phone |
91-485-2253007 |
| Fax |
91-485-2250880 |
| Email |
drnpp@sreedhareeyam.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreekanth P Namboothiri |
| Designation |
Director, Clinical Research |
| Affiliation |
Sreedhareeyam Ayurvedic Research and Development Institute |
| Address |
Nelliakkattu Mana
Kizhakombu Post Office
Koothattukulam
Ernakulam
KERALA
686662
India |
| Phone |
91-485-2253007 |
| Fax |
91-485-2250880 |
| Email |
drsreekanthnp@sreedhareeyam.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darpan Gangil |
| Designation |
Junior Research Fellow |
| Affiliation |
Sreedhareeyam Ayurvedic Research and Development Institute |
| Address |
Nelliakkattu Mana
Kizhakombu Post Office
Koothattukulam
Ernakulam
KERALA
686662
India |
| Phone |
91-485-2253007 |
| Fax |
91-485-2250880 |
| Email |
clinicalresearch@sreedhareeyam.com |
|
|
Source of Monetary or Material Support
|
| Sreedhareeyam Ayurvedic Eye Hospital and Research Centre Koothattukulam Post
Office Ernakulam District Kerala-686662 India |
|
|
Primary Sponsor
|
| Name |
Dept of AYUSH Ministry of HealthGovt of IndiaNew Delhi |
| Address |
DEPARTMENT OF AYUSH Ministry of Health and Family Welfare IRCS
BUILDINGS (MAIN and ANNEXE) RED CROSS ROAD, NEW DELHI - 110001 |
| 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 Sreekanth P Namboothiri |
Sreedhareeyam Ayurvedic Eye Hospital and Research Centre |
Corporate Office,
Kizhakombu
Post Office
Koothattukulam
Ernakulam
KERALA |
91-485-2253007
91-485-2250880
drsreekanthnp@sreedhareeyam.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of SARDI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Progressive Myopia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Subjects clinically diagnosed as progressive myopia (refractive error more than -6 diopters, associated with degenerative changes on ophthalmoscopic examination) |
|
| ExclusionCriteria |
| Details |
Subjects with any other eye complications.
Advanced degenerative changes on ophthalmoscopy like CNV, Macular scar and Retinal Detachment)
Any previous eye surgery.
Any major systemic disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Acuity |
Baseline,Second Inpatient visit, and End of study visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life Assessment Questionnaire |
Baseline and End of study visit |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/11/2011 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of the study is to evaluate the efficacy and safety of Ayurvedic treatment procedure and medications in Progressive Myopia in Sreedhareeyam Ayurvedic Eye Hospital & Research Centre, Koothattukulam, Ernakulam District, Kerala, India.
The aim of the study is to evaluate the Ayurvedic medical management which includes Ayurvedic therapies and medicines in Progressive myopia condition. This study is designed to evaluate overall effect of selected therapeutic procedures and medicines used in this study (instead of single drug or therapy). |