| CTRI Number |
CTRI/2018/06/014605 [Registered on: 22/06/2018] Trial Registered Prospectively |
| Last Modified On: |
01/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of Skin diseases in school going children |
|
Scientific Title of Study
|
prevalence of different types of Skin diseases in school going children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalaivani S |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhanthai Maruthuvam
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Department of Kuzhanthai Maruthuvam
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9790146119 |
| Fax |
04422381314 |
| Email |
drkalaivanibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi sundaram |
| Designation |
Head of the department |
| Affiliation |
National institute of siddha |
| Address |
Department of Kuzhanthai Maruthuvam
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Department of Kuzhanthai Maruthuvam
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
04422381314 |
| Email |
mmssiddha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kalaivani s |
| Designation |
PG scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhanthai Maruthuvam
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Department of Kuzhanthai Maruthuvam
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9790146119 |
| Fax |
|
| Email |
drkalaivanibsms@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ayothidoss pandithar hospital national institute of siddha tambaram sanatorium chennai |
| Address |
national institute of siddha tambaram sanatorium chennai47 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Drskalaivani |
Two government and one private school |
Panchayat union middle school,savalpoondi.
Government welfare primary school,ayambalayam.
Murugaiyan memorial model school,Anakarai.
Tiruvanamalai
TAMIL NADU |
9790146119
drkalaivanibsms@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical committe |
Approved |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L208||Other atopic dermatitis, skin diseases, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Childrens those who are having different type of skin diseases such as Eczema,Vitiligo,Psoriasis,Scabis,Nutritional deficiency and Fungal infection. |
|
| ExclusionCriteria |
| Details |
Childrens below 6 years and above 12 years |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the prevalence of different types of Skin diseases in school going children |
1 visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the prevalence base on low economic status,Malnutrition ,Poor standards of hygiene |
Zeroth day |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
22/06/2018 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a non randomized cross sectional, observational study to evaluate the Prevalence of different types of skin diseases in school going children.Total sample size of the study is 500.The study will be conducted at Ayothidoss Pandithar hospital,National Institute of siddha,Chennai.Outcome of the study will be assessed on the basis of Questionnaire |