| CTRI Number |
CTRI/2024/09/074408 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the frequency, patient satisfaction and genetic factors of psoriasis and vitiligo |
|
Scientific Title of Study
|
Assessing Prevalence, Patient Satisfaction and Genetic Risk Factors of Psoriasis and Vitiligo |
| Trial Acronym |
VP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samanvitha P |
| Designation |
Student, Pharm d IV year |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pharmacology,III Floor, Faculty of Pharmacy,Sri Ramachandra Institute of Higher Education and Research, No:1 Ramachandra Nagar, Porur, Chennai, 600116
Sri Ramachandra Institute of Higher Education and Research, No:1 Ramachandra Nagar, Porur, Chennai, 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
7550040866 |
| Fax |
|
| Email |
p0220011@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Murugesan Arumugam MPharm PhD |
| Designation |
Assistant Professor in Pharmacology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pharmacology, Faculty of Pharmacy,Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai: 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
8870151588 |
| Fax |
|
| Email |
murugesan.a@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Hemapriya V |
| Designation |
Assistant Professor in Pharmacology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pharmacology, Faculty of Pharmacy,Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai: 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9092254333 |
| Fax |
|
| Email |
hemapriya@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Hospital, Sri Ramachandra Institute of Higher Education and Research, No:1 Ramachandra Nagar, Porur, Chennai 600116, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research DU |
| Address |
No.1 Ramachandra nagar Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116 |
| Type of Sponsor |
Other [Funding Society] |
|
|
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 Murugesan Arumugam |
Sri Ramachandra Hospital, SRIHER |
Department of Pharmacology,III floor, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education Research, No:1, Ramachandra Nagar, Sri Ramachandra Nagar,Porur, Chennai:600116
Chennai
TAMIL NADU |
8870151588
murugesan.a@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, (2) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or nonpregnant female patients aged above 18 year
2. Patients with dermatological conditions like vitiligo and psoriasis
3. Active vitiligo, defined as appearance of new areas of depigmentation or progression of existing areas of depigmentation
4. Active psoriasis with shades of purple or gray scale on brown or Black skin and pink or red with silver scale on white skin.
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy or breastfeeding women
2. Alcohol or drug abuse
3. Uncooperative patients
4. Skin malignancies (current or a history of skin malignancy within 5 years preceding screening)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The prevalence of psoriasis and vitiligo, patient satisfaction with their current treatment regimen |
This study involves assessing the prevalence of psoriasis and vitiligo and patient satisfaction with the treatment with their current treatment regimen using questionnaire so this study do not have any time points. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The genetic risk factors involved & to understand the incidence of comorbidities due to the disease.
2. The impact of COVID-19 vaccination on the disease.
|
The genetic risk factors, co morbidities & impact of COVID 19 vaccine will be obtained using questionnaire for this study so there is no time points for this study |
|
|
Target Sample Size
|
Total Sample Size="435"
Sample Size from India="435"
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)
|
30/09/2024 |
| 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)
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
|
Vitiligo, Psoriasis an autoimmune disease triggered by genetic susceptibility and environmental factors. Phototherapy, using UV radiation and bakuchiol from Psoralea corylifolia reduces autoimmune destruction and shows promising anti-inflammatory effects for both conditions as per literature. This study aims to assess the prevalence, patient satisfaction, and genetic risk factors of psoriasis and vitiligo , recruiting 435 patients from SRIHER’s dermatology clinic over one year. Data will be collected through standardized questionnaires and pedigree analysis. The study will include adults with active vitiligo or psoriasis and exclude pregnant women. Data analysis using SPSS software The findings aim to enhance management and treatment strategies for these chronic dermatological disorders. |