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Clinical Trials/CTRI/2014/04/004545
CTRI/2014/04/004545
Completed
未知

To compare efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic idiopathic urticaria: a randomized, double-blind, comparative, parallel group study.

Indira Gandhi Government Medical college0 sites60 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: null- patients with chronic spontaneous urticaria
Sponsor
Indira Gandhi Government Medical college
Enrollment
60
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria
  • 1\) Those who were willing to participate in the study and comply with its procedures by signing a written informed consent.
  • 2\) Patients from Out\-Patient Department (OPD) of dermatology between age group of 18 to 65 years of either sex.
  • 3\) History of urticarial wheal and/or angioedema for at least 3 days a week for 6 consecutive weeks with no obvious cause prior to inclusion in study.
  • 4\) Mean total symptom score (24 hour reflective) \>\= 3 at screening. This includes 1\-5 number of wheals (score \>\= 1\); at least a moderate severity of pruritus (score\>\=2\).
  • 5\) Patients who were on any antihistamines except rupatidine and olopatadine were also included in the trail only after giving washout period of 7 days, irrespective of doses of the previous drugs.
  • 6\) Those who understood and agreed to adhere to the dosing and visit schedules, and agree to assess and record their symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.

Exclusion Criteria

  • Exclusion criteria
  • 1\) History of asthma or any other disease requiring chronic use of inhaled or systemic corticosteroids.
  • 2\) Subjects with acute spontaneous urticaria or all physical and other subtypes of urticaria like aquagenic, cholinergic, contact and exercise induced urticaria
  • 3\) Had been unresponsive to antihistamine treatment in the past.
  • 4\) History of allergies to study medication or unable to tolerate antihistamines.
  • 5\) Use of study drug in the last 7 days prior to baseline and not willing to take washout period.
  • 6\) Pregnant female, nursing mothers.
  • 7\) Subjects with significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or autoimmune disease

Outcomes

Primary Outcomes

Not specified

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