| CTRI Number |
CTRI/2025/10/095812 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Process of Care Changes
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Helping Tinea Patients Heal Better The Role of Pharmacist in Skin Care |
|
Scientific Title of Study
|
Impact of clinical pharmacist services on tinea patients care and therapeutic outcomes in a tertiary care teaching hospital A prospective 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 |
Dr Satish Karoli |
| Designation |
Assistant Professor |
| Affiliation |
KLE college of pharmacy |
| Address |
Department of Pharmacy Practice
Room No 15
KLE College of Pharmacy Belagavi Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
9986594048 |
| Fax |
|
| Email |
satishkaroli@klepharm.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Karoli |
| Designation |
Assistant Professor |
| Affiliation |
KLE college of pharmacy |
| Address |
Department of Pharmacy Practice
Room No 15
KLE College of Pharmacy Belagavi Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
9986594048 |
| Fax |
|
| Email |
satishkaroli@klepharm.edu |
|
Details of Contact Person
Public Query
|
| Name |
Arslan Hawaldar |
| Designation |
Intern |
| Affiliation |
KLE college of Pharmacy |
| Address |
Department of Pharmacy Practice Room No 15
KLE College of Pharmacy Belagavi
Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
886042417 |
| Fax |
|
| Email |
arslanhawaldar007@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital and Medical Research Centre |
|
|
Primary Sponsor
|
| Name |
KLE college of pharmacy |
| Address |
Nehru nagar Belagavi Karnataka 590010 |
| Type of Sponsor |
Research institution |
|
|
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 Satish Karoli |
KLEs Dr Prabhakar Kore Hospital and Medical Research Centre |
Department of Dermatology
Room no 23
Nehru Nagar Belagavi 590010
Belgaum
KARNATAKA |
9986594048
satishkaroli@klepharm.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLECOPBGM ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clinical Pharmacist Intervention |
There will be 3 follow ups carried out
7 days after consultation
7 to 14 days after the first follow up
a 3rd follow up through telephone after 15 days of the second follow up
Post intervention evaluation of quality of life treatment satisfaction and pharmacist services using validated measures such as the DLQL TSQM 9 PSPSQ type scales will be used to assess |
| Intervention |
Clinical Pharmacist Intervetion |
The patient with skin complaints at the dermatology department screened for tinea will be included in the study and a questionnaire will be carried using the HATOUM scale
Patient counselling along with a patient information leaflet will be provided to the patient
The intervention will be assessed after
7 days
7 to 14 days
15 to 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with Tinea infection
Patient aged 18 years and above of any gender
Patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Patients with mixed skin infections
Severely immunocompromised patients
Patients with cognitive impairment or those who are critically ill
Drug induced skin infection cases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the medication asherence among Tinea patients measured by the TSQM or similar adherence scales
To assesss the patient satisfaction with their therapy via TSQM or a validated satisfaction tool
Overall health outcomes related to Tinea infection tracked using HOLMES scale or another relevant health status |
7 days
7 to 14 days
15 to 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatological Quality of life improvement in Tinea patients as result of clinical pharmacist caremeasured by DLQI or equivalent |
7 days
15 days
30 days |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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)
|
04/11/2025 |
| 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="6"
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
|
This research project looks at how clinical pharmacists help patients with tinea, which is a common skin infection caused by fungus What is Tinea Tinea is a skin problem caused by fungi and can affect various parts of the body, like the scalp feet nails hands and around the groin Why Is This Study Important Many people worldwide have tinea and other skin diseases, but treatment is often not easy to get especially in countries with fewer resources. The study wants to find ways to improve care for these patients and make sure they get better treatmentWhat Did the Researchers Do The project took place at a hospital and included adult patients who were diagnosed with tinea by doctors The researchers checked how clinical pharmacists could improve how well patients follow their medicine routines and how happy they are with their treatment. They also looked at how tinea affects their daily life Patients were given simple health questionnaires before and after receiving help from pharmacists The pharmacists gave special advice checked the medicines explained how to use them correctly and answered patients questions Patients were followed up several times over weeks to see how their health changed after pharmacist support Main Goal The main aim is to see if having clinical pharmacists involved helps patients stick to their medicine feel better about their care, and live a better life while battling tinea infection Study Results The project expects that the help from pharmacists will make patients use their medicines properly understand their condition better, and enjoy improved health and satisfaction |