| CTRI Number |
CTRI/2019/03/018199 [Registered on: 20/03/2019] Trial Registered Prospectively |
| Last Modified On: |
17/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Problems of Retail Pharmacists in Tuberculosis Case Identification and Referral |
|
Scientific Title of Study
|
Barriers of community pharmacists in identification and referral of presumptive tuberculosis cases in Tiruvallur district of Tamil Nadu |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Rajanandh MG |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pharmacy Practice, Faculty of Pharmacy,
Sri Ramachandra Institute of Higher Education and Research,
Deemed to be University, Porur, Chennai
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
07598464723 |
| Fax |
|
| Email |
mgrpharm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pankaj B Shah |
| Designation |
Professor and Head |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Community Medicine,
Sri Ramachandra Medical College and Hospital, Sri Ramachandra Medical College and Research Institute,
Deemed University,
Porur, Chennai – 600116.
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
07550208565 |
| Fax |
|
| Email |
drpankajbshah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gayathri P |
| Designation |
PG student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pharmacy Practice, Faculty of Pharmacy,
Sri Ramachandra Institute of Higher Education and Research,
Deemed to be University, Porur, Chennai
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
|
| Fax |
|
| Email |
gayathri26031996@gmail.com |
|
|
Source of Monetary or Material Support
|
| ​Department of Pharmacy Practice,
Faculty of Pharmacy,
Sri Ramachandra Institute of Higher Education and Research,
Deemed to be University,
Porur, Chennai - 600 116. |
|
Primary Sponsor
Modification(s)
|
| Name |
Tuberculosis Association of India |
| Address |
The Tuberculosis association of India
3, Red Cross Road,
New Delhi - 110001.
INDIA. |
| Type of Sponsor |
Government funding agency |
|
|
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 Rajanandh MG |
Sri Ramachandra Institute of Higher Education and Research |
​Department of Pharmacy Practice, Room No. 5th floor, G-block, Faculty of Pharmacy,
Deemed to be University, Porur, Chennai - 600 116.
Thiruvallur
TAMIL NADU |
7598464723
mgrpharm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
pharmacists |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Qualified and registered pharmacist working in private pharmacies |
|
| ExclusionCriteria |
| Details |
Pharmacists unwilling to consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Human resource for health is a major shortage in most, low and middle income countries. In this context, all the allied health workers should be engaged in the concerted fight against TB which is a disease of National priority in our country. This study will help to understand and optimize the role of pharmacists in providing support for the health systems |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The report generated can be the evidence to revise the existing guidelines / training module for pharmacists for effective case identification and referral of presumptive TB cases by community pharmacists. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="205"
Sample Size from India="205"
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)
|
25/03/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Though the Government has taken enormous steps to involve the private sector in TB control, the involvement of community pharmacists in Tamil Nadu state in this regard has remained awfully low, contrary to trends in other Indian states and developed countries. There is limited data available regarding the barriers of community pharmacists of Tamil Nadu state in TB case identification and referral. |