| CTRI Number |
CTRI/2022/12/048189 [Registered on: 16/12/2022] Trial Registered Prospectively |
| Last Modified On: |
15/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A community-based study of prevalence of skin disorders in semi-urban and urban Telangana State |
|
Scientific Title of Study
|
A community-based study of prevalence of skin disorders in semi-urban and urban Telangana State |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Yeldandi |
| Designation |
Principal Investigator |
| Affiliation |
Society for Health Allied Research and Education India (SHARE INDIA) |
| Address |
Society for Health Allied Research and Education India (SHARE INDIA)
Mediciti Institute of Medical Sciences Campus
Ghanpur Village, Medchal Mandal,
Hyderabad,
Society for Health Allied Research and Education India (SHARE INDIA)
Mediciti Institute of Medical Sciences Campus
Ghanpur Village, Medchal Mandal,
Hyderabad,
Medchal
TELANGANA
501401
India |
| Phone |
9849886824 |
| Fax |
|
| Email |
vijayyeldandi@shareindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Yeldandi |
| Designation |
Principal Investigator |
| Affiliation |
Society for Health Allied Research and Education India (SHARE INDIA) |
| Address |
Society for Health Allied Research and Education India (SHARE INDIA)
Mediciti Institute of Medical Sciences Campus
Ghanpur Village, Medchal Mandal,
Hyderabad,
Society for Health Allied Research and Education India (SHARE INDIA)
Mediciti Institute of Medical Sciences Campus
Ghanpur Village, Medchal Mandal,
Hyderabad,
Medchal
TELANGANA
501401
India |
| Phone |
9849886824 |
| Fax |
|
| Email |
vijayyeldandi@shareindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Yeldandi |
| Designation |
Principal Investigator |
| Affiliation |
Society for Health Allied Research and Education India (SHARE INDIA) |
| Address |
Society for Health Allied Research and Education India (SHARE INDIA)
Mediciti Institute of Medical Sciences Campus
Ghanpur Village, Medchal Mandal,
Hyderabad,
Society for Health Allied Research and Education India (SHARE INDIA)
Mediciti Institute of Medical Sciences Campus
Ghanpur Village, Medchal Mandal,
Hyderabad,
Medchal
TELANGANA
501401
India |
| Phone |
9849886824 |
| Fax |
|
| Email |
vijayyeldandi@shareindia.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pfizer Inc |
| Address |
Plot No. C, The Capital, 1802, 18th Floor, 70, G Block Rd, Bandra Kurla Complex, Bandra East, Mumbai, Maharashtra 400051 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manjunath Dinaker |
SHARE INDIA |
6-1-126 & 127/4 Bapuji Nagar, MIGH colony, Walker Town, Secunderabd
Hyderabad
TELANGANA |
9849886824
mdinaker2511@gmail.com |
| Dr Vijay Yeldandi |
SHARE INDIA |
Society for Health Allied Research and Education India (SHARE INDIA)
Mediciti Institute of Medical Sciences Campus
Ghanpur Village, Medchal Mandal,
Hyderabad, Telangana-501401, India
Medchal
TELANGANA |
9849886824
vijayyeldanadi@shareindia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MediCiti Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Skin disorder being screened |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects age 2 years and above
2. Subjects who have skin disorders
3. Able to provide informed consent/ assent (in case of children).
4. Subjects who reside in the study area (for at least 6 months)
|
|
| ExclusionCriteria |
| Details |
1. Subjects with no skin disorders.
2. Subjects below the age of 2 years
3. Subjects unable to participate in study related procedures
4. Subjects unwilling or unable to provide informed consent/assent
5. Subjects who do not reside in the area (at 6 months) and/or are unlikely to reside in the area until end of December 2023 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| we aim to determine the prevalence of skin disorders in urban and semi urban communities and their impact on quality of life. |
12 to 13 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To determine impact on quality of life due to skin disorders
• To explore influence of predisposing conditions including influence of geography on skin disorders and quality of life |
12 to 13 months |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= "10479"
Final Enrollment numbers achieved (India)="10479" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2023 |
| Date of Study Completion (India) |
30/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Skin diseases contributed about 2% of the global burden of diseases measured in Disease Adjusted Life Years (DALYs) (1). The prevention and management of skin diseases received less attention in the past decades due to low mortality rates. However, a recent Global Burden of Disease Study finding revealed that skin diseases rank 18 in top 20 diseases in terms of DALYs and is fourth leading cause of nonfatal disease burden (2). Further, skin diseases increase clinical depression and anxiety. The prevalence and pattern of skin diseases are influenced by the overall ecosystem of the region including sociocultural milieu, topography, nutrition, genetics etc. In India, skin diseases have been profiled through hospital-based studies with low levels of prevalence (3-7) as compared to community-level. The prevalence varied from 4.2% to 11.6% in the general population. However, high prevalence has been reported (30%–40%) in pediatric population (8, 9) and 60% in a community-based survey in the central India (10). There is a dearth of data about prevalence in skin diseases among semi-urban/rural communities in Telangana. |