CTRI Number |
CTRI/2025/03/083598 [Registered on: 27/03/2025] Trial Registered Prospectively |
Last Modified On: |
26/03/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Study observing medicine being prescribed to patients with Psoriasis at SMS hospital, Jaipur |
Scientific Title of Study
|
An Observational study on Drug Prescription Pattern in Psoriasis Patients Attending Dermatology and Venereology Department at SMS Hospital, Jaipur, Rajasthan |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dinesh kumar |
Designation |
Postgraduate Resident |
Affiliation |
Sawai Man Singh Medical College Jaipur, Rajasthan, India, 302004 |
Address |
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan, India, 302004
Jaipur RAJASTHAN 302004 India |
Phone |
9887759136 |
Fax |
|
Email |
dineshsharma.ds09@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Chandan Verma |
Designation |
Professor |
Affiliation |
Sawai Man Singh Medical College Jaipur, Rajasthan, India, 302004 |
Address |
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan, India, 302004
Jaipur RAJASTHAN 302004 India |
Phone |
9414059213 |
Fax |
|
Email |
chandanverma1970@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Chandan Verma |
Designation |
Professor |
Affiliation |
Sawai Man Singh Medical College Jaipur, Rajasthan, India, 302004 |
Address |
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan, India, 302004
RAJASTHAN 302004 India |
Phone |
9414059213 |
Fax |
|
Email |
chandanverma1970@gmail.com |
|
Source of Monetary or Material Support
|
SMS Medical College and attached Hospital Jaipur, Rajasthan, India, 302004 |
|
Primary Sponsor
|
Name |
Dr. Dinesh Kumar |
Address |
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan, India, 302004 |
Type of Sponsor |
Other [Self] |
|
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 Dinesh Kumar |
Sawai Man Singh Hospital |
Room no. 20, Dermatology and Venereology Department at SMS Hospital, Jaipur, Rajasthan , India,302004 Jaipur RAJASTHAN |
9887759136
dineshsharma.ds09@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ETHICS COMMITTEE, SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL, JAIPUR |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L40||Psoriasis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1. Patients attending OPD of dermatology diagnosed with psoriasis.
2.Patients diagnosed with psoriasis with comorbidities.
3.Old and newly diagnosed patients
4.Patients who agreed to sign the informed consent form. |
|
ExclusionCriteria |
Details |
1. Pregnant and lactating patients.
2. Inpatient department patients. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. Proportion of cases where drugs were prescribed according to STGs.
2.Average number of drugs per encounter.
3.Percentage of drugs prescribed with the generic name.
4.Percentage of encounters with antibiotics prescribed.
5.Percentage of encounters with injections prescribed.
6.Percentage of drugs prescribed from Essential Drugs List (EDL). |
At baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To assess the health-related quality of life of diagnosed cases via DLQI scale.
2.To estimate the sociodemographic & clinical profile among recruited patients.
3.Patient will be sensitised for preventive measures for psoriasis. |
At baseline |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
10/04/2025 |
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 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
|
Psoriasis is a chronic, inflammatory skin condition marked by red, scaly plaques, typically on the scalp, elbows, and knees, though it can affect other areas like the hands, feet, and trunk. It involves a combination of genetic predisposition and environmental triggers such as trauma, stress, or medications, and can lead to systemic issues in various organs. The disease is characterized by epidermal hyperproliferation, inflammatory infiltration, and abnormal angiogenesis. Symptoms commonly include itching, irritation, and pain, and psoriasis significantly impacts quality of life. Various forms of psoriasis exist, including plaque, guttate, pustular, and erythrodermic types.
Treatment varies based on disease severity, with mild psoriasis managed by topical treatments like corticosteroids, emollients, and vitamin D3 analogues. More severe cases require systemic therapies or phototherapy. Evaluating prescribing patterns is essential for ensuring rational drug use, as inappropriate prescribing can lead to ineffective treatment, increased costs, and adverse effects. Adherence to prescribed medication is crucial for successful treatment, and patient preferences, treatment efficacy, and comorbidities influence medication choices. Monitoring and optimizing drug use can help minimize side effects and improve treatment outcomes. |