â??A clinical trial to study the beneficial effects of the drug â??â??Rupatadineâ?? in â??â??Allergic skin disease

Phase 3

Completed

Conditions: Health Condition 1: null- Chronic Idiopathic UrticariaHealth Condition 2: L501- Idiopathic urticaria

Registration Number: CTRI/2017/05/008624

Lead Sponsor: SRM University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improves Total Symptom score(TSS)Timepoint: At the end of 6 weeks

Secondary Outcome Measures

Name	Time	Method
Improves Dermatology Life Quality Index(DLQI), <br/ ><br>Improve Global Efficacy Score, <br/ ><br>Observing Adverse drug reaction by Visual Analogue scale.Timepoint: At the end of 6 weeks