| CTRI Number |
CTRI/2017/02/007843 [Registered on: 13/02/2017] Trial Registered Prospectively |
| Last Modified On: |
07/09/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of physical and psychological changes over quality of life in patients of psoriasis |
|
Scientific Title of Study
|
Analysis of quality of life in relation with physical and psychological morbidity in psoriasis |
| Trial Acronym |
QOLRPAPMP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1188-9716 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek Nimbark |
| Designation |
First Year Resident |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
115 First Floor New OPD Building Department of Skin and VD Sir T Hospital Jail Road Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9429587636 |
| Fax |
|
| Email |
viveknimbark@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hita Mehta |
| Designation |
Professor and Head |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
115 First Floor New OPD Building Department of Skin and VD Sir T Hospital Jail Road Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9429503188 |
| Fax |
|
| Email |
hitamehta88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hita Mehta |
| Designation |
Professor and Head |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
115 First Floor New OPD Building Department of Skin and VD Sir T Hospital Jail Road Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9429503188 |
| Fax |
|
| Email |
hitamehta88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Skin and VD Sir T Hospital Government Medical College Jail Road Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of Skin and VD |
| Address |
115 Department of Skin and VD Sir T Hospital Jail Road Bhavnagar |
| Type of Sponsor |
Government 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 Vivek Nimbark |
Sir T Hospital Bhavnagar |
115 First Floor New OPD Building Department of Skin and VD Sir T Hospital Jail Road Bhavnagar 364001
Bhavnagar
GUJARAT |
9429587636
viveknimbark@yahoo.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Suffering from skin disease Psoriasis between age group 18 to 70 years, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 18 to 70 years of age and both genders
Patients suffering from psoriasis and should not be on biologics and drugs like methotrexate and cyclosporine 3 months before and at the time of participation in the study |
|
| ExclusionCriteria |
| Details |
Patient not willing to participate not giving consent less than 18 years of age pregnant women and patients on biologics and drugs like methotrexate and cyclosporine 3 months before and at the time of participation in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Metabolic Syndrome Criteria
1 Waist Circumference Women 85 cm Men 90 cm
2 Serum Triglycerides 150 mg per dl
3 Serum HDL Women 50 mg per dl Men 40 mg per dl
4 Blood Pressure 130 by 85 mmhg
5 Fasting blood sugar more than 126 mg per dl
Dermatology Life Quality Index
Hospital and Anxiety Depression Scale |
0 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2017 |
| Date of Study Completion (India) |
08/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Psoriasis is a chronic papulosquamous disorder characterised by erythematous plaques or papules which may be associated with silvery white scales Aim of my study is to compare and assess the quality of life of the patients of psoriasis which is influenced because of the physical and psychological changes to control The study including 200 patients 100 cases of psoriasis and 100 control will be conducted in the outpatient clinic of the Department of Skin and VD Sir. T Hospital Bhavnagar Gujarat A total of 100 patients of psoriasis of both genders and all age groups will be included in the study along with the 100 control which includes the relatives accompanying the patients of psoriasis and other patients attending the clinic but not suffering from psoriasis and the conditions like diabetes and other endocrinal disorders After obtaining the consent cases and control in this study will be subjected to QOL assessment by questionnaire of Dermatology Life Quality Index DLQI Hospital Anxiety and Depression scale for psychological morbidity investigations like Serum Cholesterol Serum Triglycerides Serum HDL Blood Pressure and height measurement by standard measure tape weight by weighing machine and central obesity by standard measure tape Psoriasis Area and Severity Index PASI will also be calculated of each and every patient
|