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CTRI Number  CTRI/2022/05/042773 [Registered on: 24/05/2022] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening
Behavioral 
Study Design  Other 
Public Title of Study   Improve Rational Use of Topical Corticosteroids 
Scientific Title of Study   Assessment and Evaluation of Rational Dispensing of Topical Corticosteroids By Community Pharmacists and Its Implications On Health Science Population 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sowmya Spoorthi  
Designation  PhD Research scholar 
Affiliation  KLE college of pharmacy, KAHER 
Address  Room no: 15, Department of Pharmacy practice, KLE college of Pharmacy, KAHER, JNMC campus, Nehru nagar

Belgaum
KARNATAKA
590010
India 
Phone  8884884875  
Fax    
Email  sowmya.spoorthi27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M S Ganachari 
Designation  Prof & HOD 
Affiliation  KLE college of pharmacy, KAHER 
Address  Room no: 15 Department of Pharmacy practice KLE college of Pharmacy KAHER JNMC campus Nehru nagger
Room no: 15 Department of Pharmacy practice KLE college of Pharmacy KAHER JNMC campus Nehru nagger
Belgaum
KARNATAKA
590010
India 
Phone  9448634457  
Fax    
Email  msganachari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sowmya Spoorthi  
Designation  PhD Research scholar 
Affiliation  KLE college of pharmacy, KAHER 
Address  Room no: 15, Department of Pharmacy practice, KLE college of Pharmacy, KAHER, JNMC campus, Nehru nagar

Belgaum
KARNATAKA
590010
India 
Phone  8884884875  
Fax    
Email  sowmya.spoorthi27@gmail.com  
 
Source of Monetary or Material Support  
No Monetary Support 
 
Primary Sponsor  
Name  KAHER 
Address  JNMC,Nehru Nagar,Belgavi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sowmya Spoorthi M  KLE Hospitals  Room no: 23, Department of dermatology, 1st floor, KLE hospitals.
Belgaum
KARNATAKA 
8884884875

sowmya.spoorthi27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER ethics committee on human subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L309||Dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clinical Pharmacist Education and Awareness on use of Topical corticosteroids.  Community Pharmacist Health Science Students Patients are recruited for 6 months and follow up for 6 months 
Comparator Agent  Standard counseling   Standard treatment given for 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Registered Community Pharmacist in and around Belagavi.
Health Science Student Population of KLE University.
Patients who are prescribed with topical corticosteroid.
Patients who give history of TCs use on face.  
 
ExclusionCriteria 
Details  Health Science Students already using systemic corticosteroids.
Patients on systemic corticosteroids.
Special population like pregnant and lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Promoting rational dispensing of topical corticosteroids among community pharmacist by 1 month and 3 months followup.
Increase the awareness about topical corticosteroids among undergraduate students for pre and post 1 month and 3 months followup.
 
followup for 1 month and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
• To improve knowledge ,attitude and perception about topical corticosteroids among patients.  1 year 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "265"
Final Enrollment numbers achieved (India)="265" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/06/2022 
Date of Study Completion (India) 25/02/2023 
Date of First Enrollment (Global)  06/06/2022 
Date of Study Completion (Global) 25/02/2023 
Estimated Duration of Trial   Years="1"
Months="10"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

1)   

1)     Approval from the ethics committee will be obtained before conducting the study.

2)      KAP questionnaire & Subject Information Leaflet (PIL) will be prepared by referring to various primary, secondary, and tertiary sources.

3)      Prepared SIL(Subject Information Leaflet) will be validated for its content and design using various readability statistics (Western formula) and user readability testing.

4)      User testing questionnaires will be developed based on the content of the SILS and will also be validated.

5)      The validated KAP questionnaires will be used to identify the Knowledge ,Attitude and perception of Community pharmacist, Students and Patients.

6)      The Community pharmacist, Students, Patients will be enrolled in the study after obtaining written informed consent .

7)      All the relevant information will be collected in a specially designed data collection.

8)      The Community Pharmacist , Students and patients  will be assessed for the knowledge, Attitude and Perception level  using pre-validated tools.

9)      The enrolled Community Pharmacist after screening them and obtaining Informed Consent they will be administering  KAP questionnaires as pre test to assess knowledge Attitude and Perception.

10)    The Community Pharmacist will be requesting to attend Webinar and educational intervention by a clinical pharmacist. (Educational intervention includes the additional Information offered by the Clinical Pharmacist about Topical Corticosteroid. The pharmacist will analyse the Knowledge level from the Pre-test conducted by using KAP Questionnaires and will provide the Pharmacist education and counselling on various aspects of Topical Corticosteroids , including potency of topical corticosteroids and its common side effects, need for adherence to drug therapy. The student will be provided with the validated SIL(Subject Information Sheet), after one month followup will be taken using same KAP Questionnaires by electronic means)

11)  The enrolled Students will be randomly assigned to the two groups viz-intervention group (IG) and the Control group (CG).

12)  The Control group will receive Student Information Leaflet without Counselling  by the Clinical Pharmacist.

13)  The intervention group will receive the Counselling by the physician via Webinar and educational intervention by a clinical pharmacist. (Educational intervention includes the additional care offered by the Clinical Pharmacist. The pharmacist will analyse the Student drug therapy if any, and will provide the Student education and counselling on various aspects of Topical Corticosteroids , including diseases, drugs and its common side effects, need for adherence to drug therapy, and need and measures for lifestyle modification. The student will be provided with the validated SIL, monthly reminder regarding the drug therapy by electronic means if any)

14)  All the enrolled students in both of the groups will be called on follow up, and the responses on the knowledge level, Attitude, and perception about Topical Corticosteroids of the Students will be recorded. (A total of three times KAP Questionnaire will be administered  , i.e., baseline, after 1st month  and 3rd month .

15)  The enrolled Patients after screening them and obtaining Informed Consent they will be administering  KAP questionnaires as pre test to assess knowledge , Attitude and Perception about Topical Corticosteroids.

 

 
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