| CTRI Number |
CTRI/2021/03/031827 [Registered on: 09/03/2021] Trial Registered Prospectively |
| Last Modified On: |
01/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
EXAMINATION OF NAILFOLD CAPILLARY WITH THE HELP OF DERMATOSCOPE IN PATIENTS OF PSORIASIS AND TO SEE IT RELATION WITH METABOLIC SYNDROME |
|
Scientific Title of Study
|
ASSESSMENT OF NAILFOLD CAPILLARY CHANGES WITH USB VIDEODERMATOSCOPE IN PSORIASIS PATIENTS AND ITS ASSOCIATION WITH METABOLIC SYNDROME |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal Pal |
| Designation |
MD Student |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Dermatology
Maulana Azad Medical College
2 Bahadur Shah Zafar Marg
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8800919037 |
| Fax |
|
| Email |
drvishalrabble@mail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineet relhan |
| Designation |
Associate Professor and Guide |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Dermatology
Maulana Azad Medical College
2 Bahadur Shah Zafar Marg
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9910086636 |
| Fax |
|
| Email |
vineetrelhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vineet relhan |
| Designation |
Associate Professor and Guide |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Dermatology
Maulana Azad Medical College
2 Bahadur Shah Zafar Marg
New Delhi
DELHI
110002
India |
| Phone |
9910086636 |
| Fax |
|
| Email |
vineetrelhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Associated Lok nayak Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Vishal Pal |
| Address |
Department of Dermatology
Maulana Azad Medical College
2 Bahadur Shah Zafar Marg
New Delhi 110002 |
| 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 Vishal Pal |
Lok Nayak Hospital |
Department of Dermatology
Maulana Azad Medical College
2 Bahadur Shah Zafar Marg
New Delhi 110002
New Delhi
DELHI |
8800919037
drvishalrabble@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
| Patients |
(1) ICD-10 Condition: L40||Psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed cases of psoriasis
2. Age and sex matched healthy volunteers |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating females
2. Patients of raynauds phenomenon, paronychia, periungual traumatic lesion, Connective tissue disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare nailfold capillary changes in patients of psoriasis with controls |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the association between nailfold capillary changes in patients of psoriasis with metabolic syndrome |
9 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/04/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is an observational, case-control study assessing nailfold capillary changes with USB videodermatoscope in psoriasis patients and its association with metabolic syndrome that will be conducted in a single center in India. The primary outcome will be to compare nailfold capillary changes in patients of psoriasis with controls. The secondary outcome will be association between nailfold capillary chnages in patients with metabolic syndrome. |