drugset / Trial / NCT03250143

To Assess and Compare the Efficacy of Cyclosporine Versus Azathioprine in the Treatment of Chronic Refractory Urticaria

NCT03250143

RandomizedParallel-groupOpen-labelTreatment

Summary

Fifty six patients of CRU attending the urticaria clinic in the department of Dermatology, Venereology and Leprology at the Post Graduate Institute of Medical Education and Research, Chandigarh will be recruited in the study calculated by using equivalence analysis assuming power of 90%, significance level of 5% and standard deviation of 1 and adjusting 5% of expected drop-outs after taking written informed consent. This study is undertaken with an intention to treat the patients of chronic refractory urticaria completely. Patients will be randomized into two groups A and B using computer generated random number tables, group A will receive Cyclosporine and group B will receive Azathioprine; wherein, 28 random single and double-digit numbers from 1-56 will be selected before recruitment, and patients coming on these numbers will be randomized in a particular group. Random number generation, recruitment and randomization, were all done by the same investigator..

Timeline

Start
2016-12-06
Primary completion
2017-11
Completion
2017-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azathioprine Small molecule 1 mg/kg Oral
Comparator Azathioprine Small molecule 2 mg/kg Oral
Comparator Azathioprine Small molecule 50 mg Oral
Comparator Azathioprine Small molecule 100 mg Oral
Comparator Cyclosporine Peptide 3 mg/kg Oral
Comparator Cyclosporine Peptide 5 mg/kg Oral
Comparator Cyclosporine Peptide 200 mg Oral

Indications