| CTRI Number |
CTRI/2024/05/067585 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Quality of Life: Psoriasis Patients vs. General Population - Insights from a Cross-Sectional Study |
|
Scientific Title of Study
|
Assessing and comparing the quality of life on individuals affected by Psoriasis versus normal patient-A Cross-Sectional 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 |
Aishwarya Badkhal |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Clinical Research Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8308909047 |
| Fax |
|
| Email |
badkhalaishwarya24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Gaurav Mude |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe College of Phasrmacy Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8007095656 |
| Fax |
|
| Email |
gauravpharmacy@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Gaurav Mude |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe College of Phasrmacy Salod Wardha
MAHARASHTRA
442001
India |
| Phone |
8007095656 |
| Fax |
|
| Email |
gauravpharmacy@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institude of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institude of Higher Education and Research |
| Address |
Sawangi Wardha |
| Type of Sponsor |
Private medical college |
|
|
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 Aishwarya Balwant Badkhal |
Aacharya Vinoba Bhave Rural Hospital |
Sawangi Wardha
Wardha
MAHARASHTRA |
8308909047
badkhalaishwarya24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and research |
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 |
| Intervention |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Psoriasis Group: Individuals of with a confirmed diagnosis of psoriasis.
Control Group: Individuals without a history of psoriasis and individuals with a history of fever.
|
|
| ExclusionCriteria |
| Details |
Above 65.
General population.
Individuals with other chronic dermatological or systemic conditions affecting QoL.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in DLQI scores of patients with psoriasis and fever will be assessed. |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Response rates will be compared between the psoriasis patient and fever patient treatment groups. |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
16/07/2024 |
| 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="1"
Months="0"
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
|
Psoriasis is an
immune-mediated, chronic inflammatory disease affecting multiple aspects of
patients’ lives. Psoriasis
is a chronic inflammatory systemic disease that severely impacts patients’
quality of life. This study
aims to evaluate and compare the quality of life of individuals with Psoriasis
and those without the condition, in order to understand the significant effects
of this chronic autoimmune disease on different aspects of well-being. Psoriasis,
identified by repeated inflammatory skin symptoms, places significant physical,
emotional, and social strain on people affected. This study examines the differences in quality of life among
patients with Psoriasis compared to those without the condition using
standardized tools and thorough statistical analysis. Important factors that are examined
include how well a person can physically function, their emotional well-being,
their social connections, and how happy they are with their life in general.
The research aims to understand the specific difficulties that Psoriasis
patients experience, which can include severe physical symptoms and negative
social consequences like stigma and difficulties in social interactions.
This study also aims to highlight
the important effect of Psoriasis on various aspects of quality of life by
comparing the quality of life of Psoriasis patients with that of the general
population. In the end, the findings from this research could help in creating
specific interventions and support systems designed to improve the quality of
life for Psoriasis patients, leading to better overall well-being and health
outcomes for this group. |