FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B359||Dermatophytosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
Close