| CTRI Number |
CTRI/2023/09/057464 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
09/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Awareness of Pharmacovigilance in Ayurvedic scholars |
|
Scientific Title of Study
|
An Assessment of Knowledge, Attitude and Practice (KAP) of Pharmacovigilance in the Ayurvedic system of Medicine among Ayurvedic scholars: A cross-sectional survey study |
| 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 Shivani Ghildiyal |
| Designation |
Assistant Professor, Department of Dravyaguna |
| Affiliation |
All India Institute of Ayurveda (AIIA), New Delhi |
| Address |
All India Institute of Ayurveda, Gautam Puri Sarita Vihar Mathura Road New Delhi
New Delhi
DELHI
110076
India |
| Phone |
8765363310 |
| Fax |
|
| Email |
drshivanighildiyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Ghildiyal |
| Designation |
Assistant Professor, Department of Dravyaguna |
| Affiliation |
All India Institute of Ayurveda (AIIA), New Delhi |
| Address |
All India Institute of Ayurveda, Gautam Puri Sarita Vihar Mathura Road New Delhi
DELHI
110076
India |
| Phone |
8765363310 |
| Fax |
|
| Email |
drshivanighildiyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Ghildiyal |
| Designation |
Assistant Professor Department of Dravyaguna |
| Affiliation |
All India Institute of Ayurveda (AIIA), New Delhi |
| Address |
All India Institute of Ayurveda Gautam Puri Sarita Vihar Mathura Road New Delhi
DELHI
110076
India |
| Phone |
8765363310 |
| Fax |
|
| Email |
drshivanighildiyal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda New Delhi |
|
|
Primary Sponsor
|
| Name |
Megha Pandey |
| Address |
Department of Pharmaceutical Sciences Sir JC Bose Technical Campus Bhimtal Kumaun University Nainital Uttarakhand |
| Type of Sponsor |
Other [Self-individual] |
|
|
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 |
| Megha Pandey |
All India Institute of Ayurveda |
Department of Dravyaguna
New Delhi
DELHI |
7817802215
meghapandey774@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No health conditions |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Ayurvedic scholars including undergraduates postgraduates and doctorates willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Ayurvedic scholars including undergraduates postgraduates and doctorates not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess knowledge attitude & practice of Pharmacovigilance in the Ayurvedic system of medicine among Ayurvedic scholars |
At baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="287"
Sample Size from India="287"
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)
|
18/09/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A semi-structured questionnaire will be used for the data collection. the questionnaire is composed of four parts including the sociodemographic details, and questions to assess knowledge, attitude and practice of Pharmacovigilance among Ayurvedic scholars. |