| CTRI Number |
CTRI/2019/02/017834 [Registered on: 26/02/2019] Trial Registered Prospectively |
| Last Modified On: |
22/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of repeated fungal infection of skin on day to day life of Patient |
|
Scientific Title of Study
|
Quality of life and Clinical Pattern in Recurrent Dermatophytosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1257, Version 1 dated 19/12/2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev Gupta |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Room No. 212, 2nd
Floor, OPD Complex,
Department of Dermatology,
Maharishi Markandeshwar Institute of Medical
Sciences and Research,
Mullana, Ambala, Haryana, 133207
Ambala HARYANA 133207 India |
| Phone |
9812017161 |
| Fax |
|
| Email |
sanjeevguptadr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjeev Gupta |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Room No. 212, 2nd Floor, OPD Complex,
Department of Dermatology,
Maharishi Markandeshwar
Institute of Medical Sciences and Research,
Mullana, Ambala, 133207, Haryana
Ambala HARYANA 133207 India |
| Phone |
9812017161 |
| Fax |
|
| Email |
sanjeevguptadr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanjeev Gupta |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Room No. 212, 2nd Floor, OPD Complex,
Department of Dermatology,
Maharishi Markandeshwar
Institute of Medical Sciences and Research,
Mullana, Ambala, 133207, Haryana
Ambala HARYANA 133207 India |
| Phone |
9812017161 |
| Fax |
|
| Email |
sanjeevguptadr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar
Institute of Medical
Sciences and
Research, Mullana,
Ambala, Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala, 133207. |
| Type of Sponsor |
Private 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 Ajinkya Vinayak Gujrathi |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
Room No. 211, 2nd Floor,
Department of Dermatology,
OPD Complex,
Maharishi Markandeshwar Institution of Medical
Sciences, Mullana, Ambala, 133207 Ambala HARYANA |
9819990954
agujrathi20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MM Institute of Medical Sciences and Research, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinically diagnosed active dermatophytosis which are recurrent or recalcitrant.
2. Patients of age 18 years and above. |
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 18 years.
2. Patients having any other skin disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of species causing Dermatophytosis |
3 months after collection of samples |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life in patients of dermatophytosis |
At the time of enrollment |
| Steroid abuse in patients with recurrent dermatophytosis |
At the time of enrollment |
| Clinical pattern in recurrent dermatophysis |
At the time of enrollment |
| Anti-fungal Drug sensitivity of Organisms causing Dermatophytosis |
3 months after collection of samples |
|
|
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)
|
01/03/2019 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dermatophytosis is the most common skin disease in dermatology OPDs (Out Patient Departments) in India with an ever increasing extent and prevalence. “Recurrent†and “resistant†cases have recently been acknowledged by the medical community and are being increasingly encountered in our country, in which standard treatment guidelines have fallen short of expectations. It has a prolonged course with periods of exacerbations and remissions. The cause of increased incidence of treatment failures is seldom well understood and is not clearly defined. there is lack of data regarding the extent of the problem and the characteristics of recurrent dermatophytosis in published literature. The aim of this study is 1. To understand the clinical, social, personal and epidemiological aspects of the patients suffering from dermatophytosis 2. To study the extent and effect dermatophytosis has on an individuals’ quality of life. 3. To study steroid abuse in relation to dermatophytosis 4. To study microbiological aspects of dermatophytosis in India. This study will help us know the present (Epidemiological and Microbiological) status of this disease in India and fill the gap in current knowledge of this subject. This study hopes to highlight and understand the current scenario better; this may not only affect/change the way clinicians approach the treatment but also arm clinicians to curb emergence of resistant dermatophytosis. |