| CTRI Number |
CTRI/2025/02/080232 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Nailfold capillaroscopy in vasculitis |
|
Scientific Title of Study
|
Study of Nailfold capillaroscopy findings in Vasculitis: 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 |
Karina Khan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Bathinda |
| Address |
Department of Dermatology, first floor, OPD block, All India Institute Of Medical Sciences, Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9928380761 |
| Fax |
|
| Email |
karinakhan2306@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Bansal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bathinda |
| Address |
Department of Dermatology, first floor, OPD block, All India Institute Of Medical Sciences, Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
8287020404 |
| Fax |
|
| Email |
drshivani.derm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Bansal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bathinda |
| Address |
Department of Dermatology, first floor, OPD block, All India Institute Of Medical Sciences, Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
8287020404 |
| Fax |
|
| Email |
drshivani.derm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, All India Institute Of Medical Sciences, Bathinda |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences, Bathinda |
| Address |
All India Institute Of Medical Sciences, Jodhpur Romana, Dabwali Road, Bathinda, Punjab, 151001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Karina Khan |
All India Institute Of Medical Sciences, Bathinda |
OPD and IPD block of Department of Dermatology, General medicine, Nephrology, Paediatrics
Bathinda
PUNJAB |
9928380761
karinakhan2306@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with vasculitis by CHCC(Chapel Hill Consensus Conference Classification) |
|
| ExclusionCriteria |
| Details |
1) Patients with autoimmune connective tissue disease
2) Patients who have diabetes mellitus or peripheral vascular disease
3) Individuals who have nail disorders that could interfere with nailfold capillaroscopy
4) Patients who have cardiovascular disorders like myocardial infarction or peripheral vascular disease
5) Patients who have trauma in hand or had manicure within 2 weeks.
6) Individuals unable to comply with procedure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nailfold capillaroscopy changes in vasculitis. |
At any point of time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Different nailfold capillaroscopy patterns in different types of vasculitis |
At any point of time. |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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)
|
15/02/2025 |
| 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="1"
Months="6"
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
|
All the patients who will meet the inclusion criteria will be taken up for the study after taking written informed consent from each patient and in case if partient is less than 18 years of age, then consent will be taken from parent/guardian. After documentation of the demographic details, detailed history regarding the onset and progression of disease and thorough cutaneous examination noting the number, size, location and the type of lesion will be done (in case of cutaneous involvement) along with systemic examination to check for the systemic involvement of vasculitis. It will be done and noted on a proforma. Then Nailfold capillaroscopy will be performed using standard protocol and findings will be noted. |