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CTRI Number  CTRI/2025/08/093074 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Drug compliance among patients with Psoriasis 
Scientific Title of Study   Evaluating prescription patterns and medication adherence among patients with Psoriasis in a tertiary care hospital - A prospective Cross-sectional Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Viha Mangal Chavan 
Designation  Junior Resident 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Pharmacology Kasturba Medical College Madhav Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  9867190996  
Fax    
Email  drviha9601@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena Nayak 
Designation  Associate Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department Of Pharmacology Kasturba Medical College Madhav Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844773573  
Fax    
Email  veena.nayak@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Viha Mangal Chavan 
Designation  Junior Resident 
Affiliation  Kasturba Medical College Manipal 
Address  Department Of Pharmacology Kasturba Medical College Madhav Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  9867190996  
Fax    
Email  drviha9601@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College Manipal Madhav Nagar Udupi Karnataka 576104 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Viha Mangal Chavan  Kasturba Medical College  Department of Dermatology OPD Block Room 22 Second Floor Kasturba Hospital Kasturba Medical College Madhav Nagar Manipal Karnataka India 576104
Udupi
KARNATAKA 		 9867190996

drviha9601@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 Institutional Ethics  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L400||Psoriasis vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients aged 18 years or more diagnosed with psoriasis and on medications for atleast 3 months.
Patients prescribed at least one psoriasis related medication topical systemic or biologic at study entry.
Patients with psoriasis either as inpatient or as outpatient.
Willing and able to provide informed consent.
 
 
ExclusionCriteria 
Details  Patients with pustular psoriasis and psoriatic arthritis as the primary diagnosis.
Pregnant and Lactating females and Children.
Patients with cognitive impairments preventing self-reporting or consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Frequency of drugs prescribed Systemic, Topical, Phototherapy.
Frequency of patients who are adherent to medications.
Factors influencing adherence.
Correlation between severity and adherence.
Frequency of drug-drug interaction
 		 Baseline (Day 0). No follow up 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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)   25/08/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 study will evaluate prescription patterns and medication adherence in patients diagnosed with psoriasis attending dermatology outpatient and inpatient services in a tertiary care hospital in South India. After obtaining informed consent demographic and clinical details including age gender socioeconomic status disease duration and comorbidities will be collected from electronic medical records and patient interviews Prescription details such as drug name dosage route frequency duration and class whether topical systemic  or biologic will be recorded and potential drug drug interactions will be assessed using a standard drug interaction checker UpToDate checker. Psoriasis severity will be graded using the Psoriasis Area and Severity Index PASI. Medication adherence will be assessed using the 12 item Medication Adherence Scale and prescription refill records. No additional laboratory tests or invasive procedures will be performed for the study. Data will be analysed to determine adherence rates prescribing trends and associations between adherence disease severity and demographic or socioeconomic factors. All participant information will remain confidential and results will be reported in aggregate to ensure privacy.

 
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