| 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.â€
|
| 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
|
|
|
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
|
|
|
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. |