| CTRI Number |
CTRI/2023/08/056637 [Registered on: 18/08/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Co-relation of severity of ringworm with blood ferritin level-An observational study |
|
Scientific Title of Study
|
Correlation of severity of dermatophytosis with serum ferritin levels - A prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSarithaM |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical Collegge and Research Centre |
| Address |
Dept of DVL,Indira Gandhi Medical College and Research centre, Kathirkamam, Pondicherry
57,sixth cross st, Dakshinamoorthy Nagar, Kathirkamam.Pondicherry.
Pondicherry
PONDICHERRY
605009
India |
| Phone |
09443397873 |
| Fax |
|
| Email |
saritha_mohanan@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSarithaM |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical Collegge and Research Centre |
| Address |
Dept of DVL,Indira Gandhi Medical College and Research centre, Kathirkamam, Pondicherry
57,sixth cross st, Dakshinamoorthy Nagar, Kathirkamam.Pondicherry.
Pondicherry
PONDICHERRY
605009
India |
| Phone |
09443397873 |
| Fax |
|
| Email |
saritha_mohanan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSarithaM |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical Collegge and Research Centre |
| Address |
Dept of DVL,Indira Gandhi Medical College and Research centre, Kathirkamam, Pondicherry
57,sixth cross st, Dakshinamoorthy Nagar, Kathirkamam.Pondicherry.
Pondicherry
PONDICHERRY
605009
India |
| Phone |
09443397873 |
| Fax |
|
| Email |
saritha_mohanan@yahoo.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
|
|
Primary Sponsor
|
| Name |
DrSarithaM |
| Address |
Dept of DVL, Indira Gandhi Medical College and Research Institute, Pondicherry. |
| 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 |
| DrSarithaM |
Indira Gandhi Medical College and Research institute |
Dept of DVL, Indira gandhi Medical College and Research institute, kathirkamam, Pondicherry
Pondicherry
PONDICHERRY |
9443397873
saritha_mohanan@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi Medical College and Research Institute, Institute Ethics Commitee( Human Studies),I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of dermatophytosis aged 18 and above |
|
| ExclusionCriteria |
| Details |
The patients who have coexistent infections or inflammatory disorders or known anaemia or on iron supplementation will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| serum ferritin level |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| serum ferritin |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
30/08/2023 |
| 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
|
Any comorbidities, nature of treatment previously used and duration of treatment will be entered into predesigned case record form. The percentage of body surface area involved of the included patients will be entered into a predesigned pro-forma. Based on the affected body surface area, the severity is determined using dermatophytosis severity score (DSS) . Blood will be drawn for serum ferritin estimation. C reactive protein(CRP) levels will also be assessed in patients to determine if raised ferritin levels are due to any ongoing inflammation.If CRP is high, then that patient’s ferritin level will be excluded from statistical analysis. At the end of treatment (6 weeks), serum ferritin will be estimated again. Serum ferritin will be estimated by chemiluminescence method using immunoassay analyzer (Mindray CL900i), Iron and CRP will be estimated by photometrically using fully automated analyzer (Transasia XL640).
The relationship between ferritin level at diagnosis and severity of fungal infection will be studied using Spearman’s rank correlation. In addition, the ferritin levels of those with chronic, recurrent or relapsed dermatophytosis will be compared to those who are successfully treated using appropriate statistical tests like students t test or non-parametric tests after assessing the normality of data.
|