| CTRI Number |
CTRI/2024/04/066075 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A LOCAL APPLICATION OF HARITAKI AND SHUNTHI CHURNA LEPA IN ITCHING OF EYES |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL OF HARITAKI AND SHUNTHI CHURNA BIDALAK IN VERNAL KERATO CONJUNCTIVITIS |
| 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 Sneha Dnyaneshwar Moholkar |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Pune |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Department of Shalakya Tantra, Katraj, Dhanakawadi Campus,Pune.
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Department of Shalakya Tantra,Katraj, Dhanakawadi Campus, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8379909800 |
| Fax |
|
| Email |
sneha.moholkar-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Mulik |
| Designation |
Associate professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Pune |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Department of Shalakya Tantra, Katraj, Dhanakawadi Campus,Pune.
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Department of Shalakya Tantra, Katraj, Dhanakawadi Campus,Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9175382645 |
| Fax |
|
| Email |
sarita.mulik@bharatividyapeeth.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarita Mulik |
| Designation |
Associate professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Pune |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Department of Shalakya Tantra, Katraj, Dhanakawadi Campus,Pune.
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Department of Shalakya Tantra, Katraj, Dhanakawadi Campus,Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9175382645 |
| Fax |
|
| Email |
sarita.mulik@bharatividyapeeth.edu.in |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University ) College of Ayurved and hospital Pune - satara road Pune -43 |
|
|
Primary Sponsor
|
| Name |
DR SNEHA MOHOLKAR |
| Address |
DEPARTMENT OF SHALAKYA TANTRA, COLLEGE OF AYURVED, BHARATI VIDYAPEETH (Deemed to be University),KATRAJ DHANKAWADI CAMPUS PUNE- SATARA ROAD,PUNE |
| Type of Sponsor |
Other [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 Sneha Moholkar |
BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY) College of Ayurved And Hospital |
Bharti Vidyapeeth (Deemed to be University) College of Ayurved And hospital DEPARTMENT OF SHALAKYA
Pune
MAHARASHTRA |
8379909800
sneha.moholkar-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BV(DU)COA-Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: Abhishyand, (2) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: KAPABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
|
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from VERNAL KERATO CONJUNCTIVITIS |
|
| ExclusionCriteria |
| Details |
Existing occular surface pathology
One eyed patients
Post operative patients |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary end point of study will be patient relieved from VERNAL KERATO CONJUNCTIVITIS without any complications |
The primary end point of study will be patient relieved from VERNAL KERATO CONJUNCTIVITIS without any complications |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected to equal or improved by 10% in parameters like itching burning sensation redness photophobia lacrimation |
Baseline 3rd and 5th day |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="28"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
VERNAL KERATO CONJUNCTIVITIS is a type of allergic conjunctivitis.It is bilateral, recurrent occurs mainly in the childhood from 4-20 yrs of age.Occular allergy involves the surface of all ocular components.vernal KERATO conjunctivitis is common troublesome allergic conjunctivitis affecting mainly children and adolescent with seasonal recurrence. |