| CTRI Number |
CTRI/2023/10/058432 [Registered on: 06/10/2023] Trial Registered Prospectively |
| Last Modified On: |
03/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study Of common skin diseases in old age people in rural area of Delhi |
|
Scientific Title of Study
|
An epidemiological study Of common skin diseases among elderly male in a rural area of Delhi. |
| 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 Sunny Bhaskar |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of community medicine, 3rd floor, pathology block, Maulana Azad medical College, Bahadur shah zafar marg, New Delhi
Central
DELHI
110002
India |
| Phone |
8340630962 |
| Fax |
|
| Email |
sunnybhaskar8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 338, Department of community medicine, 3rd floor, pathology block, Maulana Azad medical College, Bahadur shah zafar marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9968604250 |
| Fax |
|
| Email |
prtickle@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunny Bhaskar |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of community medicine, 3rd floor, pathology block, Maulana Azad medical College, Bahadur shah zafar marg, New Delhi
Central
DELHI
110002
India |
| Phone |
8340630962 |
| Fax |
|
| Email |
sunnybhaskar8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur shah zafar marg, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Department of community medicine, Maulana Azad Medical College |
| Address |
Bahadur shah zafar marg, New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Sunny Bhaskar |
Jaffarpur Kalan village |
Jaffarpur Kalan, New Delhi-110073
South West
DELHI |
8340630962
sunnybhaskar8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Maulana Azad Medical College, New Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
All elderly male aged 60 years and above residing in jaffarpur kalan village will be included in study |
|
| ExclusionCriteria |
| Details |
Persons who are not able to communicate
Persons who are mentally impaired |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of skin diseases among elderly male in the study area |
will be assessed 4 weeks after data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Risk factors associated with skin diseases such as age, socio-economic status, family history, overcrowding
Proportion of individuals having impaired quality of life associated with skin disease |
will be assessed 8 weeks after collection of data |
|
|
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)
|
01/11/2023 |
| 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
|
This study aims to find out prevalence of skin diseases and quality of life associated with skin diseases among elderly male in a rural area of Delhi |