| CTRI Number |
CTRI/2023/02/050101 [Registered on: 27/02/2023] Trial Registered Prospectively |
| Last Modified On: |
24/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to find out the effect of Anjana as Dinacharya in Myopia patients. |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Pipplyadi Varti Anjana as Dinacharya in Prathama Patalagata Timira(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 Akshaya Mohandas |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Department of PG in Swasthavritta and Yoga
Alvas Ayurveda Medical College Moodubidire
Alvas Ayurveda Medical College
Moodubidire
Karnataka
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9497793939 |
| Fax |
|
| Email |
akshayamdas7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagendrakumar |
| Designation |
Professor and HOD |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Department of PG in Swasthavritta and Yoga
Alvas Ayurveda Medical College
Moodubidire
Alvas Ayurveda Medical College
Moodubidire
Karnataka
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9844471581 |
| Fax |
|
| Email |
nagendra.k18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshaya Mohandas |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Department of PG in Swasthavritta and Yoga
Alvas Ayurveda Medical College
Moodubidire
Alvas Ayurveda Medical College
Moodubidire
Karnataka
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9497793939 |
| Fax |
|
| Email |
akshayamdas7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College
Moodbidri, Dakshina Kannada, Karntaka 574227 India |
|
|
Primary Sponsor
|
| Name |
Dr Akshaya Mohandas |
| Address |
Department of PG in Swasthavritta and Yoga
Alvas Ayurveda Medical College Moodubidire |
| 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 Akshaya Mohandas |
Alvas Ayurveda Medical College |
Department of PG in Swasthavritta and Yoga
Alvas Ayurveda Medical College Moodubidire
Dakshina Kannada
KARNATAKA |
09497793939
akshayamdas7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Alvas Ayurveda Medical College Moodubidire |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: PRATHAMA-PATALAGATADOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Anjana as Dinacharya using Pippalyadi Varti Anjana in Harenu Matra once daily for 30 days in Myopia patients., Ritucarya: Not Applicable, Acara Rasayana:Not Applicable, Other:Not Applicable, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients with diminished visual acuity between the age 15 to 35 |
|
| ExclusionCriteria |
| Details |
Anjana Anarha
Patients with history of ocular trauma and surgery
Patients with other ocular pathologies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Anjana as Dinacharya in Myopia will be assessed on the basis of subjective criteria like asthenopic symptoms- headache, eyestrain and objective criteria using Visual Acuity test by Snellens Distant Vision Chart |
.Pre and post assessment will be done.Assessment will be done before the study then on 16th and 31st day then follow up on 44th and 58th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/02/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to find out the effect of Anjana as Dinacharya by using Pippalyadi Varti Anjana in Prathama Patalagata Timira (Myopia). 30 individuals diagnosed with myopia will be selected from OPD and IPD of Alvas Ayurveda Medical College, Alvas Educational Campus, camps and other referrals. The assessment will be done using the scoring methods of subjective and objective parameters. pre and post assessment will be done. Clinical symptoms will be graded, and scores will be given accordingly. |