| CTRI Number |
CTRI/2021/07/035017 [Registered on: 20/07/2021] Trial Registered Prospectively |
| Last Modified On: |
09/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to see the effect of some Ayurvedic formulation in the form of Anjana application in the treatment of Praklinna Vartma |
|
Scientific Title of Study
|
Randomized controlled trial to study the effect of Aamalaki Rasakriya Varti Anjana and Chloramphenicol with Hydrocortisone Eye Ointment in Praklinna Vartma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Supriya Anandrao Bhandare |
| Designation |
M.S. Scholar Shalakya Tantra |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalay |
| Address |
OPD.NO.09,Department of Shalakyatantra, Sane Guruji Arogya Kendra,Malwadi Road, Hadapsar,Pune
Department of Shalakyatantra, Sane Guruji Arogya Kendra,Malwadi Road, Hadapsar,Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9960828068 |
| Fax |
|
| Email |
supriya.bhandare16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilakshi Pradhan |
| Designation |
HOD and Professor Of Shalakya Tantra Department |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalay |
| Address |
OPD.NO.09,Department of Shalakyatantra, Sane Guruji Arogya Kendra,Malwadi Road, Hadapsar,Pune
Department of Shalakyatantra, Sane Guruji Arogya Kendra,Malwadi Road, Hadapsar,Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Supriya Anandrao Bhandare |
| Designation |
M.S. Scholar Shalakya Tantra |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalay |
| Address |
OPD.NO.09,Department of Shalakyatantra, Sane Guruji Arogya Kendra,Malwadi Road, Hadapsar,Pune
Department of Shalakyatantra, Sane Guruji Arogya Kendra,Malwadi Road, Hadapsar,Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9960828068 |
| Fax |
|
| Email |
supriya.bhandare16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra,Malwadi Road, Hadapsar,Pune |
| 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 |
| Vd Supriya Anandrao Bhandare |
Sane Guruji Arogya Kendra,Malwadi Road, Hadapsar |
OPD.NO.09,Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar
Pune
MAHARASHTRA |
9960828068
supriya.bhandare16@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: H010||Blepharitis, (2) ICD-10 Condition:H010||Blepharitis. Ayurveda Condition: PRAKLINNAVARTMA/KAPOTKLISHTA-VARTMA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aamalaki Rasakriya Varti |
It is a formulation of Ayurvedic Herbs prepared in the form of Varti for local Application of Varti paste on lower lid Margin (Anjana) having combination of Aamalaki Phala and Aamalaki Patra Churna will be apply on lower lid margin of both eye in the morning once in a day for 14 days. |
| Comparator Agent |
Chloramphenicol and hydrocortisone eye ointment |
It is a formulation of Chloramphenicol 1% and Hydrocortisone 0.5% in the form of eye ointment will be apply on lower lid margins of both eye at night once in a day for 14 days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from symptoms of Praklinna
Vartma like Kandu, Toda, Shopha.
2. Age - 19-50 yrs.
3. Gender- either of gender
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from complicated eye diseases or any severe ocular infections like
corneal ulcer.
2. Recently operated patients for eye diseases.
3. patient of posterior Blepharitis
4.Patient of known case of autoimmune disorders like RA or any systemic diseases like
Diabetes Mellitus, Hypertension.
5.patient suffering from infectious and contagious diseases.
6. Any malignant condition of eye . |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A clinical study to evaluate the effect of Aamalaki Rasakriya Varti Anjana in Praklinna Vartma. Parameters of efficacy will be signs, symptoms and photographs on 1st day and 14th day |
The drug will be given for 14 days . Patient will be assessed before and after treatment. Total Duration of study will be 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison between Aamalaki Rasakriya Varti Anjana and Chloramphenicol with hydrocortisone eye ointment in Praklinna Vartma. |
Total Duration of study will be 18 months |
|
|
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)
|
01/08/2021 |
| 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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is open labelled Randomized Controlled trial to evaluate the effect of Aamalaki Rasakriya Varti Anjana daily in the morning for 14 days in comparison with Chloramphenicol with Hydrocortisone eye ointment in the night for 14 days in patient affected with Praklinna Vartma. The primary outcome will be effect of Aamalaki Rasakriya Varti Anjana and the secondary outcome will be comparison between the effect of trial drug and controlled drug in management of Praklinna Vartma |