| CTRI Number |
CTRI/2019/11/022057 [Registered on: 19/11/2019] Trial Registered Prospectively |
| Last Modified On: |
15/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic treatment for improving vision of the patient |
|
Scientific Title of Study
|
Assessment of Guduchi Rasakriya Anjana in Timir with reference to Simple Myopia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anushree Ashok Pailoor |
| Designation |
PG Scholar |
| Affiliation |
YMT Ayurvedic Medical College and PG Institute |
| Address |
OPD No 5
Shalakya tantra Department
YMT Ayurvedic Medical College and PG Institute
Sector 4
Kharghar
Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
8600753407 |
| Fax |
|
| Email |
pailooranushree1893@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NUTAN RADAYE |
| Designation |
HOD |
| Affiliation |
YMT Ayurvedic Medical College and PG Institute |
| Address |
OPD No 5
Shalakya tantra Department
YMT Ayurvedic Medical College and PG Institute
Sector 4
Kharghar
Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
9820512695 |
| Fax |
|
| Email |
nutan.radaye.nr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NUTAN RADAYE |
| Designation |
HOD |
| Affiliation |
YMT Ayurvedic Medical College and PG Institute |
| Address |
OPD No 5
Shalakya tantra Department
YMT Ayurvedic Medical College and PG Institute
Sector 4
Kharghar
Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
9820512695 |
| Fax |
|
| Email |
nutan.radaye.nr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd no 5 Department of Shalakya tantra
YMT Ayurvedic Medical College and PG Institute sector 4 kharghar navi mumbai |
|
|
Primary Sponsor
|
| Name |
Shalakya tantra Department |
| Address |
YMT Ayurvedic Medical College and PG Institute |
| 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 |
| Anushree Ashok Pailoor |
OPD NO 5 SHALAKYA TANTRA DEPARTMENT YMT AYURVEDIC MEDICAL COLLEGE AND PG INSTITUTE |
YMT Ayurvedic Medical College and PG Institute
sector 4
Kharghar
Navi Mumbai
Raigarh
MAHARASHTRA |
8600753407
pailooranushree1893@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H531||Subjective visual disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchi Rasakriya Anjana |
1 karsha guduchi swarasa is mixed with 1 masha of madhu and 1 masha of saindhava
the consistensy should be like of honey
dose 1 harenu matra OD FOR 30 DAYS
type ropana anjana
Local application on the lower eyelid margin
|
| Comparator Agent |
spectacle number or refraction |
control group of 30 patients will be given spectacle number or refraction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
patients having simple myopia below 3D
patients having symptoms like watering of eyes
eye strain
headache
asthenopia |
|
| ExclusionCriteria |
| Details |
patients having any other ophthalmic conditions
patients having systemic diseases like diabetes hypertension TB etc
pregnant and lactating women
patients having pathological myopia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| result will be considered affirmative if severity of signs and symptoms particularly the visual acuity shows positive change |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms like watering of eyes headache and eye strain |
follow up up will be take on the 1st day 10th day 20th day 30th day 40th day 60th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/11/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
Patients will be selected from OPD keeping in mind the above mentioned inclusion and exclusion criterias The study will be include two groups group A will be control group with 30 patients who i will be spectacle numbers group B will be trail group with 30 patients who i will be giving guduchi rasakriya anjana once a day for 30 days with spectacle numbers patients will be called for follow up on the 1st day 10th day 20th day 30th day 40th day and 60th day data will be collected statistical analysis of data will be done final conclusion will be drawn
|