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CTRI Number  CTRI/2021/04/032718 [Registered on: 09/04/2021] Trial Registered Prospectively
Last Modified On: 08/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To assess the relation between serum markers with severity of disease and treatment response in patients with chronic spontaneous urticaria  
Scientific Title of Study   A Prospective study to assess the association of serum levels of interleukin-9, C5a, apolipoprotein A-IV with disease severity and response to antihistamines in patients with chronic spontaneous urticaria. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya  
Designation  Junior resident  
Affiliation  PGIMER, Chandigarh  
Address  Junior resident, Department of dermatology,Room number -8, 2nd floor, D block, Nehru hospital, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8107997729  
Fax    
Email  divu.bhatiya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Sendhil Kumaran 
Designation  Additional Professor 
Affiliation  PGIMER, Chandigarh  
Address  Department of dermatology, Room no. 10, 4th floor, D block, Nehru hospital, PGIMER,Chandigarh.

Chandigarh
CHANDIGARH
160012
India 
Phone  8872004023  
Fax    
Email  drsen_2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr M Sendhil Kumaran 
Designation  Additional Professor 
Affiliation  PGIMER, Chandigarh  
Address  Department of dermatology, room number -10, 4th floor, D block, Nehru hospital, PGIMER,Chandigarh.

Chandigarh
CHANDIGARH
160012
India 
Phone  8872004023  
Fax    
Email  drsen_2000@yahoo.com  
 
Source of Monetary or Material Support  
Department of dermatology, PGIMER. 
 
Primary Sponsor  
Name  Department of dermatology venereology and leprology 
Address  Pgimer, chandigarh  
Type of Sponsor  Research institution and hospital 
 
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 Divya  PGIMER  Department of dermatology, 5th floor, room number- 5003-5015, New OPD, PGIMER
Chandigarh
CHANDIGARH 
8107997729

divu.bhatiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pgimer  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L501||Idiopathic urticaria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient is called to have chronic spontaneous urticaria when there is “Spontaneous appearance of wheals, angioedema or both for > 6 weeks due to known (For example, autoreactivity, that is the presence of mast cell-activating auto-antibodies) or unknown causes” 1
Inclusion criteria
1. Patients fulfilling above definition.
2. Age ≥ 18 years.
 
 
ExclusionCriteria 
Details  1. Acute urticaria (<6 weeks disease period)
2. H/o syncopal attack and bronchospasm during preceding episodes of urticaria which is indicative of anaphylaxis.
3. Age <18 years.
4. Chronic inducible urticaria
5. Urticarial vasculitits.
6. Patients suffering from hereditary angioedema (HAE).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Primary objective
To correlate the levels of serological markers (IL-9, C5a, Apolipoprotein A-IV) with disease severity using UAS-7 and to assess the difference in levels of these markers between the patients responding to antihistamines to those who are not responding to antihistamines.
 
Baseline, 15th day, 30th day, 60th day, 90th day 
 
Secondary Outcome  
Outcome  TimePoints 
2. Secondary objective
a). To correlate the levels of serological markers(IL-9, C5a, Apolipoprotein A-IV) with total
serum IgE, Thyroid profile with anti TPO antibodies in patients with chronic spontaneous
urticaria
 
Baseline, 15days, 60days, 90 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/04/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  


“Urticaria is a mast cell derived disease which is characterized by short lived itchy wheals,

angioedema or both”. It can either present as acute urticaria with onset of symptoms and disease 

duration of less than 6 weeks or chronic urticaria where disease duration is equal or more than 6 

weeks. Onset of chronic urticaria can be spontaneous or induced. It affects 10-30% of population 

once or more in a lifetime. According to EAACI guidelinesfirst line symptomatic treatment 

for the management of urticaria is 2nd generation non sedating antihistaminics. If standard dosing 

is not effective, it is recommended to hike the dose upto 4 times. Few patients of urticaria tend to 

be more severely affected, and does not even respond  to 4 fold increased dosage of 

antihistaminics.  In these antihistamine refractory urticaria, other modalities used are 

Omalizumab, cyclosporine,  azathioprine, methotrexate and phototherapy, plasmapheresis and 

corticosteroids, IVIG. 

 

There is enough evidence to say that chronic urticaria is characterized by a systemic pro-

inflammatory stateThere are two major mechanisms described for the pathogenesis of   

chronic urticaria. One mechanism involves dysregulation in intracellular signaling pathways in 

the mast cells and basophils which causes defects in trafficking or function of these cells. The 

second mechanism is decribed by the development of circulating antibodies against FcεRI or IgE 

on both mast cells and basophils.

IL-9 was initially considered a Th2-cytokine but now it is said to be a product of Th9 specialized 

 

subset  of CD4+ T helper cells. IL-9 is a pleiotropic cytokine. It has both direct and indirect

 

effects on various cell types. IL-9 is a potent growth factor which promots the proliferation as 

 

well as differentiation of  mast cells. Patients with CSU patients showed markedly increased 

 

numbers of Th9 cells in peripheral blood, though levels were not as high as seen in acute 

 

urticaria. It indicates a high expression of IL-9 in peripheral blood because of the positive 

 

correlation between Th9 and IL-9 Study by Feng et al suggested that IL-9 and IL-10 

 

contribute to the pathogenesis of Chronic Spontaneous Urticaria via activation of the JAK/STAT 

 

signalling pathway.

 

Recent studies have suggested a vital role for apolipoproteins in the pathogenesis of various 

 

inflammatory diseases.  ApoA-IV is known to have an inhibitory effect on basophil histamine 

 

release, which indicates that it could be a potential  therapeutic target for allergic diseases. It is 

 

an endogenous anti‐inflammatory protein which potently represses effector cell functions in 

 

eosinophils. Therefore, ApoA‐IV if applied exogenously may characterize a fresh 

 

pharmacological approach for the treatment of allergic inflammation and other eosinophil driven 

 

disorders.

         

 

A possible role for complement in pathogenesis of chronic urticaria is supported by lack of 

 

enhancement of serum pathogenic IgG if the serum is scarce in the second or fifth components of 

 

complement. Hence an anaphylatoxic complement fragment, most likely C5a, was considered to 

 

mediate the direct activation of basophils and mast cells. Kikuchi et al confirmed that cross-

 

linking of the IgE receptor α subunit by pathogenic IgG in patients with CU leads to release of 

 

histamine, which is augmented by complement, and they verified that C5a is responsible for that 

 

augmentation.


 

 The proposed study aims to identify biomarkers by correlating their levels with disease 

 

activity and response to treatment. It could be useful to predict the future evolution and 

 

response to treatment or to monitor the activity of CSU and the efficacy of treatment

 

 
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