| CTRI Number |
CTRI/2020/05/025034 [Registered on: 05/05/2020] Trial Registered Prospectively |
| Last Modified On: |
19/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Vanshmul raskriya varti with Triphala raskriya varti in Squamous Blepharitis |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Vanshmul raskriya varti anjan with Triphala raskriya varti anjan in Squamous Blepharitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vidya Shivaji Pandhare |
| Designation |
PG student |
| Affiliation |
PDEAs College of Ayurved and Research centre, Akurdi, Pune. |
| Address |
PDEAs Ayurved Rugnalaya and Sterling multispeciality hospital, Shalakytantra, OPD No.122,Sector no.27,Nigdi Pradhikaran, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9404503995 |
| Fax |
|
| Email |
gotovids@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Bhoite |
| Designation |
Assistant Professor, Shalakyatantra |
| Affiliation |
PDEAs College of Ayurved and Research centre, Akurdi, Pune. |
| Address |
PDEAs College of Ayurved and Research centre, Shalakyatantra department, 3rd Floor, Sector no.25,Nigdi Pradhikaran, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9423585654 |
| Fax |
|
| Email |
aparnabhoite@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidya Shivaji Pandhare |
| Designation |
PG student, Shalakyatantra |
| Affiliation |
PDEAs College of Ayurved and Research centre, Akurdi, Pune. |
| Address |
PDEAs Ayurved Rugnalaya and Sterling multispeciality hospital, Shalakytantra, OPD No.122,Sector no.27,Nigdi Pradhikaran, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9404503995 |
| Fax |
|
| Email |
gotovide@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research centre, Third floor, shalkyatantra department, sector no.25 , Nigdi pradhikaran, Pune. |
|
|
Primary Sponsor
|
| Name |
Principal PDEAs College of Ayurved and Research centre |
| Address |
PDEAs College of Ayurved and Research centre, sector no.25 , Nigdi pradhikaran, Pune. |
| Type of Sponsor |
Private medical college |
|
|
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 Vidya Shivaji Pandhare |
PDEAs Ayurved rugnalaya and sterling multispeciality hospital,Nigdi pradhikaran, Pune. |
Shalakyatantra department ,
opd no 122, Nigdi pradhikaran, Pune-411044
Pune
MAHARASHTRA |
8308307616
gotovids@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Triphala raskriyavarti anjan |
Group B will be treated with Triphala raskriyavarti anjan containing amlaki, haritaki, bibhitaki.
Dose - 0.1mg.
Applied from Kaninika to apangsandhi.
Given once in a day for 7 consecutive days which includes followup on 7th and 15th day. |
| Intervention |
Vanshmul raskriyavartianjan |
Group A will be treated with Vanshmul raskriya vartianjan. Dose - 0.1mg.
Applied from kaninika to apangsandhi.
Given once in a day for 7 consecutive days which includes followup on 7th and 15th day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient having symptoms of squamous blepharitis. |
|
| ExclusionCriteria |
| Details |
1.Recently operated patient.
2.One eyed patient.
3.Known lid malignancy.
4.Patient suffering from any lid abnormality. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and study the efficacy of vanshmul raskriyavarti anjan once in a day for 7 consecutive days as compared to triphala raskriyavarti anjan for 7 consecutive days in squamous blepharitis. |
15 days with follow up on 7th and 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe any serious adverse effects. |
15 days with follow up on 7th and 15th 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
|
N/A |
|
Date of First Enrollment (India)
|
07/06/2020 |
| 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)?
|
|
Brief Summary
|
Now a day with increased use of vehicles, industrialization and pollution the hazardous effects are seen on human health. Following factors are responsible for ocular diseases. Food habits like fast food and high calories food. Watching TV ,mobile and computers constantly. Shift duties, life style (e.g. Night awakening etc.) Eye strain, refractive errors, cosmetics, hair dandruff. In present era sign-symptoms of Blepharitis can see commonly due to lifestyle . If it is not treated in time it may leads to severe complications. To avoid such complications there is importance of immediate treatment. To avoid complications from modern medicine, it is planned to evaluate the efficacy of vanhmul raskriyavarti anjan . According to ayurved, blepharitis is cough pradhan disease anjan chikitsa is given in this. Vansh is pittaghna, kaphghna, shothhar, crimighna, kushthghna. Triphala is chakshushya, tridoshhar, kandughna and these are used in blepharitis. |