| CTRI Number |
CTRI/2016/01/006539 [Registered on: 18/01/2016] Trial Registered Retrospectively |
| Last Modified On: |
18/01/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Tarpana and Anjana kriya in Myopia
|
|
Scientific Title of Study
|
A CLINICAL STUDY ON COMPARISON BETWEEN AKSHI-TARPANA AND ANJANA IN THE MANAGEMENT OF TIMIRA W.S.R TO MYOPIA
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DABHI DHRUVA |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U.
JAMNAGAR
GUJARAT
361008
India
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U.
JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9429094994 |
| Fax |
|
| Email |
dhruvadabhi24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majusha Rajgopala |
| Designation |
PROFESSOR |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U.
JAMNAGAR
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U.
JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9428400759 |
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Majusha Rajgopala |
| Designation |
PROFESSOR |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U.
JAMNAGAR
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U.
JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9428400759 |
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGT AND RA |
| Address |
IPGT AND RA, G.A.U. JAMNAGAR GUJARAT 361008 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dhruva Dabhi |
DEPARTMENT OF SHALAKYA TANTRA I P G T & R A, Jamnagar 361008 |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR GUJARAT 361008 India
Jamnagar
GUJARAT |
9429094994
Dhruvadabhi24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
refractive errors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group a |
Tarpana with Triphladi ghrita
Oral compound(Anubhuta yoga) will be same
|
| Comparator Agent |
Group b |
Anjana with Vimaladi varti
Oral compound(Anubhuta yoga) will be same
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Timira - Myopia upto -6D within the age group of 7-30 years with normal fundus |
|
| ExclusionCriteria |
| Details |
Patient having any other known ocular pathology eg. cataract, corneal opacity, H/O iridocyclitis, Glaucoma ,other Retinal diseases etc.
Patient below age of 7 years and above 30 years.
Patient having myopia above -6D.
Patient having myopic degenerative changes.
Patient having Juvenile Diabetes mellitus.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in diopteric power of spectacles |
two months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of myopia |
two months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
10/02/2015 |
| 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
|
no |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Few studies have been conducted on efficacy of tarpana and anjana in myopia but still not any comparative study has been carried out in any institute between anjana and tarpana to know which is better in Timira so it decided to compare the efficacy of two local procedure anjana and tarpana |