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CTRI Number  CTRI/2024/05/068189 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Single Arm Study 
Public Title of Study   A study designed to evaluate food allergies in patients experiencing chronic itching conditions such as Atopic Dermatitis or Chronic Urticaria. 
Scientific Title of Study   Clinical association of food hypersensitivity in patients with Atopic Dermatitis or Chronic Urticaria 
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 Madhav Agrawal 
Designation  Junior Resident MD 
Affiliation  Kasturba Medical College, Mangalore 
Address  Skin OPD - 9, KMC Hospital, Attavar, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9535692736  
Fax    
Email  madhavagrawal9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gatha M Upadya 
Designation  Professor and Head, Dept. of Dermatology 
Affiliation  Kasturba Medical College, Mangalore 
Address  Skin OPD - 9, KMC Hospital, Attavar, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845314028  
Fax    
Email  gatha.upadya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Gatha M Upadya 
Designation  Professor and Head, Dept. of Dermatology 
Affiliation  Kasturba Medical College, Mangalore 
Address  Skin OPD - 9, KMC Hospital, Attavar, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845314028  
Fax    
Email  gatha.upadya@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Mangalore, Light House Hill Road, Hampankatta, Mangalore, Karnataka, 575001 
 
Primary Sponsor  
Name  Dr. Madhav Agrawal 
Address  Skin OPD - 9, KMC Hospital, Attavar, Mangalore, Karnataka, 575002 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhav Agrawal  District Wenlock Hospital  Skin OPD - 35, District Wenlock Hospital, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA 		 9535692736

madhavagrawal9@gmail.com 
Dr Madhav Agrawal  KMC Hospital, Attavar  Skin OPD - 9, KMC Hospital, Attavar, Mangalore
Dakshina Kannada
KARNATAKA 		 9535692736

madhavagrawal9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L500||Allergic urticaria, (2) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  After stopping the food allergen  The improvement in clinical features noted after stopping the specific food allergens. 
Comparator Agent  Before stopping the food allergen  This will be the baseline clinical features with which the patient will present initially to the outpatient department. 
Intervention  Skin Prick Testing  Skin prick testing will be done for all patients presenting with clinical features suggestive of Atopic Dermatitis or Chronic Urticaria. This test will help find out the positive food allergens in the participants. Patients will be asked to stop consuming the positive food allergens for 6 weeks. Comparison will be done between symptoms before and after stopping the allergen. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients presenting with clinical features of atopic dermatitis or chronic urticaria.
2. Patients who are willing to give informed written consent for enrollment into the study.  
 
ExclusionCriteria 
Details  1. Pediatric age group patients up till the age of 18.
2. Patients with active wheals and dermographism positive on examination.
3. Patients who have taken antihistamines and steroidal drugs in the last 5 days of the skin prick testing.
4. Patient with unavailability of sites for skin prick testing due to disease involvement.
5. Patients who are not willing to give informed written consent for the study. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Clinical manifestations of atopic dermatitis and chronic urticaria  Follow-up after every 2 weeks for next 6 weeks.
Total study duration is 18 months.  
 
Secondary Outcome  
Outcome  TimePoints 
Impact of specific food allergens on the severity of atopic dermatitis and chronic urticaria.  Follow-up after every 2 weeks for next 6 weeks.  
Assessing improvements in symptoms and quality of life following allergen avoidance  Follow-up after every 2 weeks for next 6 weeks.  
Identification of specific food allergens triggering these conditions using skin prick testing  Follow-up after every 2 weeks for next 6 weeks. 
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
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)   01/07/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [madhavagrawal9@gmail.com].

  6. For how long will this data be available start date provided 30-11-2025 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a time-bound, institution-based, observational, cross-sectional study over a six-week follow-up period, exploring the clinical correlation between food hypersensitivities and skin conditions such as atopic dermatitis and chronic urticaria in adults. Using skin prick tests to identify allergens, the study aims to enhance patient outcomes by effectively managing and preventing exacerbations through targeted allergen avoidance. Addressing a notable knowledge gap, particularly in adult populations, the study seeks to offer valuable insights into better, personalized treatment strategies by providing comprehensive clinical and laboratory analyses. 
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