| CTRI Number |
CTRI/2025/05/086208 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical and dermoscopy of mucocutaneous features of autoimmune connective tissue disorders |
|
Scientific Title of Study
|
Clinico-dermoscopic study in mucocutaneous features of autoimmune connective tissue disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geetika |
| Designation |
Junior Resident |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
Guru Gobind Singh Medical College and Hospital, Sadiq Road, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
7888661323 |
| Fax |
|
| Email |
geetikaaggarwal0101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BK Brar |
| Designation |
Professor |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
House No 637, Street No 4, Lajpat Nagar, Kotkapura
Faridkot
PUNJAB
151204
India |
| Phone |
9814120250 |
| Fax |
|
| Email |
drbalvinderbrar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BK Brar |
| Designation |
Professor |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
House No 637, Street No 4, Lajpat Nagar, Kotkapura
Faridkot
PUNJAB
151204
India |
| Phone |
9814120250 |
| Fax |
|
| Email |
drbalvinderbrar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Gobind Singh Medical College and Hospital, Sadiq Road, Faridkot, Punjab 151203, India |
|
|
Primary Sponsor
|
| Name |
Dr Geetika |
| Address |
Guru Gobind Singh Medical College and Hospital, Sadiq road, Faridkot, 151203, India |
| 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 Geetika |
Guru Gobind Singh Medical College and Hospital, Faridkot |
Skin OPD, 1st Floor, Guru Gobind Singh Medical Hospital, Sadiq road, Faridkot
Faridkot
PUNJAB |
7888661323
geetikaaggarwal0101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Guru Gobind Singh Medical College and Hospital, Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient of any age and sex with autoimmune connective tissue disorders based on clinical picture
Patients who are willing to sign the written consent prior to participation of study |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to sign the written consent prior to participation of study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical and dermoscopic findings will be correlated, documented and their pictorial record maintained. |
At the time of presentation to skin OPD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/05/2025 |
| 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="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
|
A written informed consent will be obtained from each patient before starting the study. Diagnosis of autoimmune connective tissue disorders will be made on basis of clinical examination and lab investigations. A detailed history and clinical examination will be conducted. Dermoscopic examination will be done using hand held self illuminated Heine Delta 30 with 10x magnification. The dermoscopic characteristics like morphology of vessels, distribution of vessels, color of scales, distribution of scales, follicular findings, morphologies/color and other additional findings will be looked for and data collected. Photographic documentation of both clinical and dermoscopic pictures will be done and findings will be correlated. |