| CTRI Number |
CTRI/2026/03/106079 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of pharmacist provided health education on ASHA workers knowledge and practices |
|
Scientific Title of Study
|
Effectiveness of pharmacist intervention in Knowledge, attitude and practice of ADR reporting and pharmacovigilance among TB healthcare workers in Kolhapur City- A Quasi Experimental 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 |
Vikrama simha reddy |
| Designation |
Assistant professor |
| Affiliation |
Sarojini college of pharmacy |
| Address |
Department of Pharmacology, sarojini college of pharmacy,
rajendra nagar, kolhapur, maharashtra.
Kolhapur
MAHARASHTRA
416007
India |
| Phone |
8056126889 |
| Fax |
|
| Email |
vikram6889.scop@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikrama simha reddy |
| Designation |
Assistant professor |
| Affiliation |
Sarojini college of pharmacy |
| Address |
Department of pharmacology, sarojini college of pharmacy.
Rajendra nagar, kolhapur
Kolhapur
MAHARASHTRA
416007
India |
| Phone |
8056126889 |
| Fax |
|
| Email |
vikram6889.scop@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikrama simha reddy |
| Designation |
Assistant professor |
| Affiliation |
Sarojini college of pharmacy |
| Address |
Department of pharmacology, sarojini college of pharmacy
Rajendra nagar, kolhapur
Kolhapur
MAHARASHTRA
416007
India |
| Phone |
8056126889 |
| Fax |
|
| Email |
vikram6889.scop@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kolhapur Municipal Corporation TB Control Society. 1st floor, eagle pride building, kolekar tikti, mangalwarpeth, kolhapur.Pin:416012. India |
|
|
Primary Sponsor
|
| Name |
vikrama simha reddy |
| Address |
Department of pharmacology, sarojini college of pharmacy, rajendra nagar, kolhapur, pin: 416004. Maharashtra |
| Type of Sponsor |
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 Rupali Yadav |
Kolhapur municipal corporation TB control society |
1st floor, eagle pride building, mirajkar kolekar tikti, mangalwar peth, kolhapur. Pin 416012
Kolhapur
MAHARASHTRA |
9860489998
dtomhkmc@rntcp.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, rajashree chhatrapati shahu maharaj government medical college, kolhapur. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable- educational intervention among ASHA workers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Pharmacist-led educational intervention |
A behavioral educational intervention consisting of structured health education delivered by a registered pharmacist to ASHA workers. The intervention includes interactive verbal counselling supported by printed educational material covering [the importance of pharmacovigilance and steps to report ADR]. The intervention will be delivered in one session, lasting approximately 40 minutes. No drug, vaccine, medical device, or biological agent is administered. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Current employment as an accredited social health activist in Kolhapur city.
Direct involvement in TB patient care or TB treatment monitoring (screening, DOTS
administration, counselling, and follow-up) for at least the last 3 months. Available for the study period (able to attend baseline and follow-up
assessments/training sessions). All participants Aged more than 18 years and give consent
Able to communicate in the study language-Marathi, Hindi |
|
| ExclusionCriteria |
| Details |
Those who are not directly involved in TB patient care.
Participants unavailable during the study follow-up period.
Declines to provide informed consent.
Unable to complete study assessments. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in knowledge score regarding pharmacovigilance and ADR reporting among ASHA workers assessed using a structured questionnaire. |
Baseline (pre-intervention), immediately after the intervention, and short follow up (2 weeks) after the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
23/03/2026 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Manuscript under preparation |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a quasi experimental, non randomised, interventional study conducted as part of an undergraduate (B.pharm) thesis. This study aims to evaluate the impact of pharmacist led educational (behavioral) intervention on knowledge and practice related to ADR reporting among ASHA workers. The intervention consists of structured health education delivered by final year B. pharm students using verbal counseling and printed educational materials. The primary purpose of the study is to assess the change in knowledge and practice scores following the educational intervention. The study hypothesizes that the pharmacist led educational intervention will result in a significant improvement in knowledge and practice among ASHA workers. |