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CTRI Number  CTRI/2024/01/061885 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 19/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   An Interventional KAP survey of pharmacists/chemists regarding skin fungal infection in Himachal Pradesh 
Scientific Title of Study   Impact assessment of IEC intervention on knowledge, attitude and practice (KAP) of community pharmacists / chemists regarding skin dermatophyte infection in Himachal Pradesh.”  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manju daroach 
Designation  Assistant Professor 
Affiliation  AIIMS BILASPUR 
Address  Room number 702 Hospital block B Department of Dermatology AIIMS Bilaspur

Bilaspur
HIMACHAL PRADESH
174001
India 
Phone  9592923210  
Fax    
Email  dr.manju.derma@aiimsbilaspur.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Manju daroach 
Designation  Assistant Professor 
Affiliation  AIIMS BILASPUR 
Address  Room number 702 Hospital block B Department of Dermatology AIIMS Bilaspur


HIMACHAL PRADESH
174001
India 
Phone  9592923210  
Fax    
Email  dr.manju.derma@aiimsbilaspur.edu.in  
 
Details of Contact Person
Public Query
 
Name  Manju daroach 
Designation  Assistant Professor 
Affiliation  AIIMS BILASPUR 
Address  Department of Dermatology AIIMS Bilaspur


HIMACHAL PRADESH
174001
India 
Phone  9592923210  
Fax    
Email  dr.manju.derma@aiimsbilaspur.edu.in  
 
Source of Monetary or Material Support  
IADVL Glowderma research grant 
 
Primary Sponsor  
Name  Indian association of Dermatologists Venereologists and leprologists 
Address  Indian association of dermatologists venereologists and leprologists 
Type of Sponsor  Other [official society of Indian Dermatologists] 
 
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 Manju Daroach  AIIMS Bilaspur  Room number 702, Hospital Block B, Department of Dermatology AIIMS Bilaspur
Bilaspur
HIMACHAL PRADESH 
9592923210

dr.manju.derma@aiimsbilaspur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-BHR AIIMS bilaspur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PHARMACISTS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BEHAVIOURAL INTERVENTION 6 months   INFORMATION EDUCATION AND COMMUNICATION IEC will be given through powerpoint presentation to a group by health educator. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Chemists and Pharmacists(Retail chemists with B pharma/D pharma degree holders) in 5 districts of State 
 
ExclusionCriteria 
Details  THOSE NOT GIVING CONSENT 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Prevalence of knowledge, attitude & practice of pharmacists/chemists & druggists regarding dermatophyte infections.
2. The effectiveness of IEC in terms of KAP outcomes of pharmacists/chemists & druggists regarding dermatophyte infections by comparing the mean scores for KAP before & after intervention.
 
BASELINE AND AT 6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
The indicators for pharmacists/chemists & druggists performance in dispensing medicines for dermatophyte infections with respect to their KAP are age, years of working experience, educational level, and the availability of copies of prescriptions for dispensing medicines.
 
6 MONTHS 
 
Target Sample Size   Total Sample Size="460"
Sample Size from India="460" 
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 4 
Date of First Enrollment (India)   01/02/2024 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Dermatophyte infections of skin are one of the commonest dermatoses seen in dermatology clinics in India and has become an emerging public health concern. In recent years there is an outbreak of recurrent and chronic dermatophytosis. Today, we are facing an onslaught of chronic and recurrent dermatophytosis in volumes never encountered previously.

What has led to such a catastrophic situation in the Indian scenario is a hot topic of epidemiological and clinical research. Some predisposing factors particularly relevant to India are wide over-the-counter (OTC) availability and rampant use of topical steroid and antifungal combinations by the patients themselves or unrestricted prescription of these products by quacks and general practitioners.(1) Topical and oral antifungals in suboptimum and irrational regimens are the most often misused medications in India, which are prescribed by various medical specialists/pharmacists/chemists who tend to label a majority of skin lesions as “fungal infections.” (1)The availability of such medications OTC is adding to the current situation. Cost of these medications may also be another factor for nonadherence or poor compliance.(1)

On website of centre for disease control (CDC) there is a mention of this problem of recalcitrant dermatphytosis in India. Here people can buy creams containing strong steroids without a prescription. Many of these steroid creams also contain antifungal and antibacterial medicines, and the labels say that the cream can be used to treat fungal infections.(2) Also, healthcare providers in India report seeing more cases of severe dermatophytosis in people who have used these combination medications.(3),(4–6) These infections have been reported to cover large parts of the body, last for months or longer, and spread to family members.(6)

As chemists in India have an important role in dispending OTC drugs, capturing the knowledge, attitudes, and practices (KAP) of pharmacists regarding fungal infection is important for developing future community health action strategies and plans. We plan to conduct a KAP survey among  pharmacists and chemists  across 5 districts of Himachal Pradesh which caters around more than half of himachal population. We will also conduct an education IEC programme post KAP survey and reassess KAP immediately post IEC and  after 6 months. This will further help to intervein an important factor in this emerging menace of chronic and recalcitrant dermatophytosis.

 
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