| CTRI Number |
CTRI/2024/01/061954 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
26/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Nailfold capillaroscopic changes in psoriasis patients |
|
Scientific Title of Study
|
Nailfold capillaroscopic changes in psoriasis patients: A prospective controlled hospital based study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhavi Chhokra |
| Designation |
Junior Resident |
| Affiliation |
Department of Dermatology,Venereology and Leprosy, Dr. RPGMC, Kangra at Tanda, Himachal Pradesh |
| Address |
Department of Dermatology, Venereology and Leprosy, Dr. RPGMC, Kangra at Tanda, Kangra, Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7838061508 |
| Fax |
|
| Email |
vaibhavichhokra96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof KS Mehta |
| Designation |
Head of Department |
| Affiliation |
Department of Dermatology, Venereology and Leprosy, Dr. RPGMC, Kangra at Tanda, Himachal Pradesh |
| Address |
Department of Dermatology, Venereology and Leprosy, Dr. RPGMC, Kangra at Tanda, Kangra, Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418457647 |
| Fax |
|
| Email |
drkaranindermehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof KS Mehta |
| Designation |
Head of Department |
| Affiliation |
Department of Dermatology, Venereology and Leprosy, Dr. RPGMC, Kangra at Tanda, Himachal Pradesh |
| Address |
Department of Dermatology, Venereology and Leprosy, Dr. RPGMC, Kangra at Tanda, Kangra, Himachal Pradesh
HIMACHAL PRADESH
176001
India |
| Phone |
9418457647 |
| Fax |
|
| Email |
drkaranindermehta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Rajendra Prasad Government Medical College |
| Address |
Dr. RPGMC, Kangra at Tanda, Himachal Pradesh |
| 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 Vaibhavi Chhokra |
Dr. RPGMC, Tanda |
Room no. 135, Dept of DVL, Dr.RPGMC,Tanda
Kangra
HIMACHAL PRADESH |
7838061508
vaibhavichhokra96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. RPGMC IEC |
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 |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients of psoriasis with or without psoriatic arthritis |
|
| ExclusionCriteria |
| Details |
1. pregnant and lactating women
2. Connective tissue disorders
3. patients with coagulopathy/acrocyanosis/Raynauds
4. patients on vasoactive therapies or anticoagulants
5. patients with any skin disease or therapy affecting the area of interest for nailfold capillaroscopy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study nailfold capillaroscopic changes in patients of psoriasis & comparing with healthy controls |
at a single point of time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study patient characteristics & their associations with specific nailfold capillaroscopic patterns |
at a single point of time |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
06/02/2024 |
| 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 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
|
This is a controlled study to evaluate nailfold capillaroscopic changes in patients of psoriasis and identifying association of patient characteristics with the same. Nailfold capillaroscopy can indicate microvascular injury thereby helping in early detection and timely intervention for metabolic abnormalities. |