Skip to content

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

Evaluation of the Efficacy and Safety of Rupatadine & Loratadine in Chronic Idiopathic Urticaria - A Randomized Single-Blind Comparative Clinical Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008624
Enrollment
60
Registered
2017-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Idiopathic Urticaria Health Condition 2: L501- Idiopathic urticaria

Interventions

Intervention1: Rupatadine: Rupatadine 10mg once daily for 6 weeks Control Intervention1: Loratadine: Loratadine 10 mg once daily for 6 weeks

Sponsors

SRM University
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Improves Total Symptom score(TSS)Timepoint: At the end of 6 weeks

Secondary

MeasureTime frame
Improves Dermatology Life Quality Index(DLQI), Improve Global Efficacy Score, Observing Adverse drug reaction by Visual Analogue scale.Timepoint: At the end of 6 weeks

Countries

India

Contacts

Public ContactDr F Syed Hussain

SRM University

dr.syedhussain91@gmail.com7598308776

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026