| CTRI Number |
CTRI/2025/11/097455 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Disease Severity Affects Quality of Life in People with Alopecia Areata |
|
Scientific Title of Study
|
Impact of Disease Severity on Quality of Life in Alopecia Areata: A Cross-Sectional Study Using SALT Score and DLQI |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIRBHAY DAMOR |
| Designation |
3RD YEAR RESIDENT DOCTOR |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
115 SKIN OPD,SIR T HOSPITAL JAIL ROAD BHAVNAGAR
Bhavnagar
GUJARAT
364001
India |
| Phone |
9737407197 |
| Fax |
|
| Email |
nirbhaydamor97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HITA MEHTA |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT OF DVL |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE,BHAVNAGAR |
| Address |
115 SKIN OPD, 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 NIRBHAY DAMOR |
| Designation |
3RD YEAR RESIDENT DOCTOR |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE,BHAVNAGAR |
| Address |
115 SKIN OPD, SIR T HOSPITAL,JAIL ROAD, BHAVNAGAR
Bhavnagar
GUJARAT
364001
India |
| Phone |
9737407197 |
| Fax |
|
| Email |
nirbhaydamor97@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR NIRBHAY DAMOR |
| Address |
115 SKIN OPD,SIR T HOSPITAL,JAIL ROAD,BHAVNAGAR |
| 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 NIRBHAY DAMOR |
SIR T HOSPITAL,BHAVNAGAR |
115 SKIN OPD
Bhavnagar
GUJARAT |
9737407197
nirbhaydamor97@gmail .com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTE GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L639||Alopecia areata, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Alopecia Areata from age 18 years to 60 years |
|
| ExclusionCriteria |
| Details |
Patients of Alopecia Areata having any other known systemic illness,cutaneous illness and psychological disorder which can affect quality of life for example patient who are known case of diabetes, hypertension,depression |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of life in patients with Alopecia Areata attending tertiary care hospital using standard dermatology life quality index (DLQI) questionnaire |
AT THE END OF 5 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/11/2025 |
| 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="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Aim/Goal To
assess the quality of life in patients with Alopecia Areata.
Objectives:
Primary:
To assess the quality of life in patients with Alopecia
Areata attending tertiary care hospital using standard dermatology life quality index
(DLQI) questionnaire.
Secondary:
To correlate disease severity,
measured by the Severity of Alopecia Tool (SALT) score, with quality of life
impairment.
Study population Clinically
diagnosed cases of Alopecia Areata coming to Dermatology OPD of Sir T Hospital,
Bhavnagar from Monday to Saturday.
Sample size All the
patients fulfilling inclusion and exclusion criteria during the data collection
from October 2025 to January 2025.
Study duration 5 months
Study site / Settings (Outpatient
department of Dermatology, GMC and Sir T hospital, Bhavnagar.
Study procedures:
·
After taking approval from ethics committee, GMC Bhavnagar study will be
initiated
·
Patients coming to dermatology OPD & those fulfilling inclusion criteria will be included
·
Those patients fulfilling inclusion criteria, will be interviewed to
assess for Alopecia Areata and classified as per Severity of Alopecia Tool and for quality of life DLQI questionnaire (translated
in patient’s vernacular language)
·
interview will be done by maintaining privacy of study participants
Data will be collected, entered in MS excel
and statistical analysis will be done by using appropriate statistical software. |