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CTRI Number  CTRI/2024/06/068441 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 25/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to assess psychological problems and biochemical parameters in patients of chronic spontaneous urticaria  
Scientific Title of Study   Clinical and Psychological Profile in Patients of Chronic Spontaneous Urticaria: A hospital based 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  Dr Poorva Maheshwari 
Designation  Academic Junior Resident 
Affiliation  Kasturba Medical College MAHE, Manipal 
Address  Room No 21, second floor, Old OPD Block Department of Dermatology, Venereology and Leprosy, Kasturba Hospital, Madhav Nagar, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  7568349545  
Fax    
Email  poorva1100@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varsha M shetty 
Designation  Associate Professor 
Affiliation  Kasturba Medical College MAHE, Manipal 
Address  Room No. 21, second floor, old OPD block Department of Dermatology, Venereology and Leprosy, Kasturba Hospital, Madhav Nagar, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9902394514  
Fax    
Email  varsha.shetty@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Ravindra N Munoli 
Designation  Associate Professor 
Affiliation  Kasturba Medical College MAHE, Manipal 
Address  Room No. 33, third floor, old OPD block Department of Psychiatry Kasturba Hospital, Madhav Nagar, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9972028881  
Fax    
Email  ravindra.nm@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College MAHE Manipal, Tiger circle, Madhav Nagar, Udupi, Karnataka, India PINCODE 576104 
 
Primary Sponsor  
Name  Dr Poorva Maheshwari 
Address  Room No. 21, second floor, Old OPD block, Department of Dermatology, Venereology and Leprosy, Kasturba Hospital, Madhav Nagar, Manipal, Udupi, Karnataka, India PINCODE 576104 
Type of Sponsor  Other [Self] 
 
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 Poorva Maheshwari  Kasturba Hospital  Room No. 21, second floor, old OPD block, Department of Dermatology, Venereology and Leprosy, Kasturba Hospital, Madhav Nagar, Manipal, Udupi, Karnataka
Udupi
KARNATAKA 		 7568349545

poorva1100@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L501||Idiopathic urticaria, (2) ICD-10 Condition: L509||Urticaria, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Clinically diagnosed patients of chronic spontaneous urticaria.
2. Patients willing to give consent to participate in the study.
3. Patients not on any continuous treatment for chronic spontaneous urticaria for last two weeks.
 
 
ExclusionCriteria 
Details  1.Population under the age of 18 years.
2.Patients diagnosed as acute urticaria.
3.Patients having angioedema without urticaria.
4.Other variants of urticaria.
5.Diagnosed cases of psychiatric illnesses and/or on any psychiatric medications.
6.Any other coexistent chronic pruritic dermatological condition.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Investigating the frequency of psychiatric comorbidities among individuals with chronic spontaneous urticaria.  OPD Visit 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluating the clinical and biochemical characteristics of individuals with chronic spontaneous urticaria.  OPD Visit 
Examining how chronic spontaneous urticaria affects patient quality of life considering the continuous medication they need and the chronic nature of the disease which imposes a significant burden on them.   OPD Visit 
 
Target Sample Size   Total Sample Size="217"
Sample Size from India="217" 
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)   15/06/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - 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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [poorva1100@gmail.com].

  6. For how long will this data be available start date provided 18-09-2024 and end date provided 18-08-2030?
    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 is a single center, hospital based observational study in which the frequency of  psychological morbidities and quality of life will be assessed in patients of chronic spontaneous urticaria. It will be assessed using the DASS-21(Depression, Anxiety, Stress Scale - 21) questionnaire and DLQI(Dermatology Life Quality Index) questionnaire. The study also involves correlating the disease activity (based on the general condition of the patient assessed by history and clinical examination of the patient)  with the biochemical parameters of the patient by means of the regular investigations done as a part of regular consultation. This study will help us assess the psychological morbidity in patients of chronic spontaneous urticaria so that necessary psychological interventions can be planned. 
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