| CTRI Number |
CTRI/2025/02/081023 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To examine the result of Drushtiprada Varti Anjana effect in Simple Myopia |
|
Scientific Title of Study
|
A Randomised Control Clinical Trial To Evaluate The Efficacy Of Drushtiprada Varti Anjana In The Management Of Pratham Patalgat Timira W. S. R. To Simple Myopia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishnavi Shailesh Patil |
| Designation |
MS Shalakyantantra Scholar |
| Affiliation |
L K R Ayurvedic Mahavidyalay Gadhinglaj |
| Address |
Shalakyatantra Department
1st floor
OPD no 49
Late Kedari Redekar Ayurvedic Mahavidyalay Gadhinglaj.
P2 , M. I.D. C. Area, Shendri Mal ,Gandhinglaj , Kolhapur .
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7249645777 |
| Fax |
|
| Email |
psiddhesh634@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam G Belgaonkar |
| Designation |
MS Shalakyatantra |
| Affiliation |
L K R Ayurvedic Mahavidyalay Gadhinglaj |
| Address |
Shalakyatantra department
1 st floor
OPD no 49
Late Kedari Redekar Ayurvedic Mahavidyalay P.G. Gadhinglaj. P2, M.I.D.C. Shendri Mal, Gadhinglaj, Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8605657046 |
| Fax |
|
| Email |
Dr.poonam2785@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi Shailesh Patil |
| Designation |
MS Shalakyatantra Scholar |
| Affiliation |
L K R Ayurvedic Mahavidyalay Gadhinglaj |
| Address |
Shalakyatantra department
1 st floor
OPD no 49
Late Kedari Redekar Ayurvedic Mahavidyalay P.G. Gadhinglaj. P2, M.I.D.C. Shendri Mal, Gadhinglaj, Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7249645777 |
| Fax |
|
| Email |
psiddhesh634@gmail.com |
|
|
Source of Monetary or Material Support
|
| L K R Ayurvedic College and Research Centre Gadhinglaj. P2 , M. l. D. C. Area, Shendri Mal, Gandhinglaj, Kolhapur.
PIN code 416502
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi Shailesh Patil |
| Address |
Shalakyatantra department
1st floor
OPD no 49
Late Kedari Redekar Ayurvedic Mahavidyalay P. G. Gandhinglaj. P2 M. I. D. C. Area, Shendri Mal, Gandhinglaj, Kolhapur, Maharashtra.
PIN code 416502
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Poonam G Belgaonkar |
L K R Ayurvedic Mahavidyalay Gadhinglaj |
Shalakyatantra department
1st floor
OPD no 49
Late Kedari Redekar Ayurvedic Mahavidyalay P.G. Gadhinglaj. P2, M.I.D.C. Area, Shendri Mal, Gadhinglaj, Kolhapur 416502
Maharashtra, India
Kolhapur
MAHARASHTRA |
8605657046
dr.poonam2785@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| L K R Ayurvedic Mahavidyalay Gadhinglaj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Myopia |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Drushtiprada varti , Reference: Gad nigrah 3rd chapter 260 th shlok, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -Drushtiprada Varti Anjana will be used in patients of simple myopia in 1 Harenu dosage | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chandrodaya varti, Reference: Chakradutta 59th chapter 101 shlok, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -Chandrodaya Varti Anjana will be used in patients of simple myopia in 1 Harenu dosage |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients with simple myopia with low error less than or equal to minus 3Dwith opthalmoscopic findings |
|
| ExclusionCriteria |
| Details |
Patients of moderate myopia minus 3D to minus 6D.
Patients of high myopia greater than or equal to minus 6D.
Hypermetropia, astigmatism, presbyopia.
Axial length greater than 28
Patient with ocular pathology, cataract, glaucoma, retinopathy, corneal ulcer,conjunctivitis. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Drushtiprada varti Anjana in simple myopia |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse reaction if any |
21 days |
|
|
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 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is single blind randomized controlled clinical study to evaluate the efficacy of Drushtiprada varti Anjana in Simple myopia. Total 60 patients of age 18 to 35 years of both sexes will be randomly selected for this trial and divided into two groups. Group A - Will be treated with Drushtiprada varti Anjana. Group B - Will be treated with Chandrodaya varti Anjana. |