| CTRI Number |
CTRI/2019/01/017044 [Registered on: 11/01/2019] Trial Registered Prospectively |
| Last Modified On: |
09/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A survey of school going children affected by sight problems followed by a study to assess the effect of an Ayurveda treatment |
|
Scientific Title of Study
|
An Open Label Prospective Clinical Study to Assess the Efficacy of an Ayurvedic Treatment Protocol in School Going Children Affected with Refractive Errors Based on a Cross Sectional Survey Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| En. No 17AYU6AYU1017 dated July 2017 Version 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreekanth NP |
| Designation |
Principal Investigator |
| Affiliation |
Sreedhareeyam Ayurvedic Eye Hospital and Research Center |
| Address |
Room No.04
Nelliakkattumana, Kizhakombu, PO, Koothattukulam, Kerala
Ernakulam
KERALA
686662
India |
| Phone |
9745005914 |
| Fax |
|
| Email |
drsreekanthnp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ratnaprava Mishra |
| Designation |
Guide |
| Affiliation |
Mandsaur University |
| Address |
Professor & HOD
Department of Kayachikitsa
Mandsaur Institute of Ayurveda & Research
Mandsaur University.
Mandsaur
MADHYA PRADESH
458001
India |
| Phone |
|
| Fax |
|
| Email |
rpmishra@meu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sreekanth NP |
| Designation |
Principal Investigator |
| Affiliation |
Sreedhareeyam Ayurvedic Eye Hospital and Research Center |
| Address |
Room No.04
Nelliakkattumana, Kizhakombu, PO, Koothattukulam, Kerala
KERALA
686662
India |
| Phone |
9745005914 |
| Fax |
|
| Email |
drsreekanthnp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sreekanth NP
Chief medical Officer
Sreedhareeyam Ayurvedic Eye hospital and Research Center
Nellakkattumana
Kizhakombu
Koothattukulam
Ernakulam District-686662
Kerala |
|
|
Primary Sponsor
|
| Name |
Sreekanth NP |
| Address |
Sreedhareeyam Ayurvedic Eye Hospital and Research Center
686662 |
| Type of Sponsor |
Other [Investigator Initiated Study] |
|
|
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 |
| Sreekanth NP |
Sreedhareeyam Ayurvedic Eye Hospital and Research Center |
Room No.4160
Center of Excellence Building
Nelliakkattumana, Kizhakombu, PO, Koothattukulam, Kerala 686662
Ernakulam
KERALA |
9745005914
drsreekanthnp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Mandsaur Institute of Ayurved Education and Research,Bhunyakhedi, Madhya Pradesh 458001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H527||Unspecified disorder of refraction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of Refractive Error as per ICD-10-CM H52.711
>6/60 Uncorrected Visual Acuity
|
|
| ExclusionCriteria |
| Details |
Legal Blindness
Any eye condition other than refractive errors such as Keratoconus,glaucoma etc
Long standing systemic illness like Type 1 DM, Thyroid disorders, Nephropathy syndrome, Auto immune disorders(RA,SLE,Psoriasis etc)
On any other long term medication
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Best corrected Visual Acuity |
8th Day,15th Day,30th Day and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Uncorrected Visual Acuity |
8th Day,15th Day,30th Day and 60th day |
| Reduction in Refractive error |
8th Day,15th Day,30th Day and 60th day |
| Stoppage of Spectacle use |
8th Day,15th Day,30th Day and 60th day |
| Subjective symptoms |
8th Day,15th Day,30th Day and 60th day |
|
|
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)
|
01/02/2019 |
| 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) |
Open to Recruitment |
|
Publication Details
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a study conducted as part of the PhD thesis submission at Mandsaur University,Madhaya Pradesh,India. The present study assess the prevalence of refractive errors in school children in Kerala and assess the reasons based on Ayurved Nidana or causes. This is followed by a Clinical Study on the efficacy an Ayurveda Treatment protocol in managing and treating refractive errors in Children. The purpose of the study is to assess the Ayurvedic reasoning in understanding and treating refractive errors. |