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CTRI Number  CTRI/2020/02/023523 [Registered on: 24/02/2020] Trial Registered Prospectively
Last Modified On: 03/07/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Frequency of arthritis in patients of psoriasis 
Scientific Title of Study   Frequency of Psoriatic Arthritis in Psoriasis patient and their clinical correlates 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumeet Singla 
Designation  Associate Professor (Medicine) 
Affiliation  Maulana Azad Medical College 
Address  Department of Medicine Room No. 115, First floor, B L Taneja block Maulana Azad Medical College Bahadur Sha Zafar Marg New Delhi

Central
DELHI
110002
India 
Phone    
Fax    
Email  sumeetsingla555@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sumeet Singla 
Designation  Associate Professor (Medicine) 
Affiliation  Maulana Azad Medical College 
Address  Department of Medicine Room No. 115, First floor, B L Taneja block Maulana Azad Medical College Bahadur Sha Zafar Marg New Delhi


DELHI
110002
India 
Phone    
Fax    
Email  sumeetsingla555@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sumeet Singla 
Designation  Associate Professor (Medicine) 
Affiliation  Maulana Azad Medical College 
Address  Department of Medicine Room No. 115, First floor, B L Taneja block Maulana Azad Medical College Bahadur Sha Zafar Marg New Delhi


DELHI
110002
India 
Phone    
Fax    
Email  sumeetsingla555@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, New Delhi 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Bahadur Shah Zafar Marg New Delhi 
Type of Sponsor  Government medical college 
 
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 Sumeet Singla  Lok Nayak Hospital  OPD Block, Jawaharlal Nehru Marg
Central
DELHI 
9810104431

sumeetsingla555@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Maulana Azad Medical College an Associated Lok Nayak Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L405||Arthropathic psoriasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All subjects with Psoriasis, diagnosed by a Dermatologist on the basis of clinical and histologic examinations are eligible for study.
Patients will be recruited from the Out patient Department(OPD), Department of Dermatology, Lok Nayak Hospital, New Delhi. Patients will be invited to take part in the study during their regular visits
 
 
ExclusionCriteria 
Details  Subjects that had received a new drug under investigations in the last 30 days.
Patients with history of any condition that could interfere in the capacity to understand the requirement of the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Frequency of Psoriatic Arthritis among Psoriasis patients  At the end of the study 
 
Secondary Outcome  
Outcome  TimePoints 
clinical correlation of age, gender, site and severity of psoriatic lesion, smoking, Body Mass Index of Psoriasis patients with Psoriatic Arthritis.
 
At the end of the study 
correlation of Biochemical Parameters of patients of Psoriatic Arthritis among Psoriasis Patients.   At the end of the study 
compare the Quality of Life in patients of Psoriasis with Psoriatic Arthritis and those without it.
 
At the end of the study 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/03/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

It is very important to diagnose psoriatic arthritis at an early stage in order to prevent irreversible joint damage and this can affect greatly the quality of living of the patient. Dermatologists are at an excellent seat to diagnose psoriatic arthritis at an early stage in the patients of psoriasis visiting dermatological Out Patient Department(OPD)  Comprehensive data of prevalence and morbidity are still lacking in the Indian subcontinent. It is perhaps underdiagnosed in Indian settings or may be confused with other Rheumatological diseases like Rheumatoid Arthritis and Osteoarthritis. To provide optimal therapy to all patients of Psoriasis Arthritis it is important to know the prevalence, clinical patterns, burden of disease, and economic considerations.

In this study we will analyse the Prevalence of PsA and clinical correlates in the patient population of Psoriasis.

Interviewer –administered Questionnaire (as enclosed) will be used to collect socio-demographic characters like age; religion; education; occupation; residence; relevant history of the disease including onset, duration, progression of Psoriasis, body part invoved aggravating and relieving and associated factors, family history and associated comorbidities; Koebner’s phenomenon; presence of nail Psoriasis; treatment of Psoriasis(steroid therapy). 

Patients will be screened for Psoriatic Arthritis using Early Arthritis for Psoriatic Patients (EARP ranging from 0 to 10 where score greater than equal to 3 is considered screening positive)

Severity of the Psoriasis will be assessed by Psoriasis Area and severity score(PASI score ranges from 0 to 72, mild 0 to 3, moderate 3 to 10, and severe >10) and Nail Psoriasis severity Index (NAPSI score ranges from 0 to 160). 

Quality of life of Patient with Psoriasis And Psoriatic Arthritis will be assessed using Dermatology Life Quality Index(DLQI ranges from 0 to 30 with score 10 or above indicating severe )  and The Indian version of Health Assessment Questionnaire (HAQ) 

Baseline investigations will be done from the Blood sample (a maximum of 10ml) collected from every patient like Complete Blood Count(CBC), Erythrocyte sedimentation Rate(ESR), C- reactive protein(CRP), Liver Function Test(LFT), Kidney function test(KFT), Lipid Profile, Rheumatoid Factor(RF), Random blood Sugar(RBS), Radiography for the affected  joints will performed. 5ml of blood sample collected from every patient will be stored at -80°C for future analysis of specific biomarkers for Psoriatic Arthritis. 

An informed consent will be taken from all the patients included in the study. 

SCREENING

All patients will be screened for Psoriatic Arthritis using Early Arthritis for Psoriatic Patients (EARP)

All the patients who will be screening positive will be referred to rheumatologist for confirmatory test

CONFIRMATION

Appropriate radiological investigations will be carried out. X rays will be reported by a Radiologist. The final Diagnosis and Classification of Psoriatic Arthritis will be made by the Rheuamatologist on the basis of Classification Criteria for psoriatic Arthritis (CASPAR).

ANALYSIS 

The estimated prevalence of Psoriatic Arthritis among Psoriasis patients will be determined. We will also evaluate any significant clinical correlation between the development of Psoriatic Arthritis in Psoriatic Patients and known patient and disease characteristics. We will also study the difference in the Quality of Life in Psoriatic patients with psoriatic Arthritis and those without it


 
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