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CTRI Number  CTRI/2017/05/008624 [Registered on: 23/05/2017] Trial Registered Prospectively
Last Modified On: 11/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   ​A clinical trial to study the beneficial effects of the drug ​​Rupatadine​ in ​​Allergic skin disease 
Scientific Title of Study   Evaluation of the Efficacy and Safety of Rupatadine & Loratadine in Chronic Idiopathic Urticaria - A Randomized Single-Blind Comparative Clinical Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr V Sathyanarayanan 
Designation  Professor Of Pharmacology 
Affiliation  SRM University 
Address  Department of Pharmacology SRM Medical College Hospital and Research Centre SRM University SRM Nagar Potheri Kattankulathur Post Kancheepuram District TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  9384633405  
Fax    
Email  satya672000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr F Syed Hussain 
Designation  Post Graduate 
Affiliation  SRM University 
Address  Department of Pharmacology SRM Medical College Hospital and Research Centre SRM University SRM Nagar Potheri Kattankulathur Post Kancheepuram District TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  7598308776  
Fax    
Email  dr.syedhussain91@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr F Syed Hussain 
Designation  Post Graduate 
Affiliation  SRM University 
Address  Department of Pharmacology SRM Medical College Hospital and Research Centre SRM University SRM Nagar Potheri Kattankulathur Post Kancheepuram District TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  7598308776  
Fax    
Email  dr.syedhussain91@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical College Hospital and Research Centre SRM University SRM Nagar Potheri Kattankulathur Post Kancheepuram District TAMIL NADU 603203 India 
 
Primary Sponsor  
Name  SRM University 
Address  SRM Nagar, Potheri, Kattankulathur, Kancheepuram District, Near Potheri Railway Station, Chennai, Tamil Nadu 603203 
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 
Prof Dr V Sathyanarayanan  SRM Medical College Hospital  Department of Dermatology Out Patient Department SRM Nagar Potheri Kattankulathur Post Kancheepuram District
Kancheepuram
TAMIL NADU 		 9384633405

satya672000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Chronic Idiopathic Urticaria, (1) ICD-10 Condition: L501||Idiopathic urticaria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Loratadine  Loratadine 10 mg once daily for 6 weeks 
Intervention  Rupatadine  Rupatadine 10mg once daily for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Man or woman aged between 18 to 65yrs old.
2.Documented history of active CIU (urticaria wheals) for at least three days per week over the last 6 weeks.
3.Active CIU(labeled as moderate pruritus) for at least 3 days (not necessarily consecutive days) in the week before inclusion with a total score of active CIU labeled as at least a moderate severity of pruritus (score≥2) for these 3 days.
4.Those who were willing to participate in the study and comply with its procedures by signing a written informed consent. 
 
ExclusionCriteria 
Details  1.Patients suffering from other forms of urticaria, with significant concomitant illness (e.g., malignancies or hepatic, psychiatric, endocrine or other major systemic diseases).
2.Pregnant women, lactating mothers, females on oral contraceptive pills.
3.Patients on antihistaminic therapy for 72 hours, or steroids for one
month, were excluded from the study.
4.Patients with Drug Allergy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improves Total Symptom score(TSS)  At the end of 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improves Dermatology Life Quality Index(DLQI),
Improve Global Efficacy Score,
Observing Adverse drug reaction by Visual Analogue scale. 		 At the end of 6 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/06/2017 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="14" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   References 1.Gimenez-Arnau A1, Pujol RM, Ianosi S, Kaszuba A, Malbran A, Poop G, Donado E, Perez I, Izquierdo I, Arnaiz E; Rupatadine Urticaria Study Group, Rupatadine in the treatment of chronic idiopathic urticaria: a double-blind, randomized, placebo-controlled multicentre study, Allergy. 2007 May;62(5):539-46. 2.Maiti R1, Jaida J, Raghavendra BN, Goud P, Ahmed I, Palani A,Rupatadine and levocetirizine in chronic idiopathic urticaria: a comparative study of efficacy and safety , Drugs Dermatol. 2011 Dec;10(12):1444-50. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

PURPOSE:

It is part of MD thesis proposal

BACKGROUND:

·        Urticaria is a transient vascular reaction pattern characterized by circumscribed, edematous, itchy lesions, usually lasting for a few hours to one or two days.

·        In particular, chronic urticaria is characterized by the occurrence of wheals 
daily or almost daily for a period of at least six weeks, with an estimated lifetime prevalence of 0.5% across all populations studied. 

·        Although individually Loratadine and Rupatadine are efficacious for CIU, unique findings in some studies indicate a likelihood of differences between these two drugs.

·        Its pathogenesis involves mainly histamine and also other mediators, including platelet-activating factor (PAF) and tumor necrosis factor-α (TNFα). In the absence of an exact etiology, H1 -antihistaminics are the mainstay of treatment. Loratadine is widely prescribed for CIU.

·        Rupatadine, a newer antihistaminic, has PAF receptor antagonist activity and has shown anti-TNF-α activity in vitro. These additional anti-inflammatory effects may improve its efficacy.

·        Therefore, this study has been conducted to compare the therapeutic efficacy and tolerability of Rupatadine and Loratadine in patients suffering from CIU.

·        The relative absence of data in this domain is an incentive to further explore the aspect of the disease.

AIM:

To Compare the Efficacy and Safety of Loratadine and Rupatadine in patients with Chronic Idiopathic Urticaria.

OBJECTIVES:

1.     To evaluate whether Rupatadine improves Total  Symptom score(TSS) in CIU in comparision with Loratadine.

2.     To evaluate whether Rupatadine improves Dermatology Life Quality Index(DLQI)  compared  with Loratadine.

3.     To evaluate whether Rupatidine improve Global Efficacy Score compare to Loratadine.

4.     To evaluate safety of Rupatadine by Observing Adverse drug reaction by Visual Analogue scale compare to Loratadine.

STUDY DESIGN:

1.Prospective and Interventional Study.

2.Randomized Single - Blind Study.

3.The Total Sample Size of 60(30 subjects in each group).

MODE OF SELECTION OF SUBJECTS:

Randomized Selection Pattern 

METHODOLOGY:

It will be Prospective,Interventional and comparative study comprising of 60 subjects with Chronic Idiopathic Urticaria patients at SRM MCH & RC. Based on Inclusion and Exclusion Criteria subjects will be grouped into two. Subjects who received Loratadine 10mg once dailyconsidered Group 1 and Rupatadine 10mgonce daily considered Group 2.Both group consists of 30 subjects in Each. Subjects will be followed up to 6 weeks.

Data collection:  

Data will be collected from the patient’s case sheet and will be entered in patient Proforma after obtaining permission from the Head of the department, Dermatology.

The Parameters are:

1. Demographics Profile:  Age, Gender, BMI

2. Past Medical History, Family History, Personal History

3.Blood Pressure

4. Blood Investigation: Total Leucocyte Count, DC Neutrophil,

DC Lymphocyte, DC Eosinophil, Absolute Eosinophil Count.

5. Adverse Reactions:

6. Time for Symptom Relief:

7.Total Symptom Score(TSS), Dermatology Life Quality Index(DLQI),Global Efficacy Score(GES).


 
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