| CTRI Number |
CTRI/2020/02/023595 [Registered on: 26/02/2020] Trial Registered Prospectively |
| Last Modified On: |
25/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Instilation of Bilwadi yoga Drops in Allergic Conjuctivitis |
|
Scientific Title of Study
|
RANDOMISED CONROL STUDY OF BILWADI YOG ASHCHYOTAN IN MANAGEMENT OF VATAJ NETRA ABHISHYANDA WITH SPECIAL REFERENCE TO SIMPLE ALLERGIC CONJUNCTIVITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rutuja Rajendra Sawant |
| Designation |
post graduation in shalakyatantra |
| Affiliation |
hon shri annasaheb dange ayurvedic medical college ashta |
| Address |
hon shri annasaheb dange ayurvedic medical college ashta Tal walwa Dist sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9096928785 |
| Fax |
|
| Email |
rusawant1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Suresh Wagh |
| Designation |
Head of department shalakyatantra |
| Affiliation |
hon.shri.annasaheb dange ayurvedic medical college ashta |
| Address |
Hon Shri Annasaheb dange ayurved medical college Ashta Tal walwa Dist Sangli
Dept Shalakyatantra
Hon Shri Annasaheb dange ayurved medical college Ashta Tal walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9881035578 |
| Fax |
|
| Email |
drsureshwagh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rutuja Rajendra Sawant |
| Designation |
post graduation in shalakyatantra |
| Affiliation |
hon shri annasaheb dange ayurvedic medical college ashta |
| Address |
hon shri annasaheb dange ayurvedic medical college ashta Tal walwa Dist sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9096928785 |
| Fax |
|
| Email |
rusawant1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Ashta |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta Tal Walawa Dist Sangli Maharashtra |
| 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 |
| rutuja |
Dr Rutuja Rajendra Sawant |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta
Sangli
MAHARASHTRA |
9096928785
023422410103
rusawant1@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: H108||Other conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilwadi yog kwath |
Bilwadi yog kwath of 2 drops 4 times for 15 days |
| Comparator Agent |
Olopatadine eye drops |
olopatadine eye drops instillation in the affected eye one drop 2times in day for 15 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with eye irritation
Both eyes red
Laceration of both eyes |
|
| ExclusionCriteria |
| Details |
Abhishyanda associate with corneal ulcer,trachoma,allergic asthama |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Randomised control study of bilwadi yog aschyotan in the management of Vataj Abhishyanda with special refferance to allergic conjunctivitis |
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| study the physiochemical analysis of bilwadi yog |
15 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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2020 |
| 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="0"
Months="0"
Days="7" |
|
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
|
Clinical research project named as " Randomised control study of Bilwadi Yog Aschyotana in the management of Vataj Abhishyanda with special referance to simple allergic conjunctivitis " will be conducted with support of Hon.Shri.Annasaheb Dange Ayurved Medical College Ashta. In the current era people are exposed to pollution and they are suffering from Vataj Abhishyanda and to treat the disease with the help of Ayurveda here making sincere effort. |