Status:
COMPLETED
To Assess and Compare the Efficacy of Cyclosporine Versus Azathioprine in the Treatment of Chronic Refractory Urticaria
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Chronic Refractory Urticaria
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief 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 b...
Detailed Description
Available definition for chronic refractory urticaria (CRU) is chronic spontaneous urticaria, with disease duration of at least 6 months or above, which is not controlled with four fold increased dosa...
Eligibility Criteria
Inclusion
- Available definition for chronic refractory urticaria (CRU) is chronic spontaneous urticaria, with disease duration of at least 6 months or above, which is not controlled with four fold increased dosage of antihistamines (as per EAACI guidelines) figure1, given for at least three consecutive months and requiring repeated courses of oral corticosteroids.
- Age ≥ 18 years.
Exclusion
- Patients giving history of fainting, bronchospasm during previous attacks of urticaria that is suggestive of anaphylaxis.
- Urticaria\< 6 weeks.
- Age \<18 years.
- Physical and pressure urticaria.
- Urticarial vasculitits.
- Pregnant and lactating patients.
- Cataract, hepatic or renal diseases, severe infections, poorly controlled hypertension
- Concomitant intake of drugs like nephrotoxic drugs (gentamycin, vancomycin, amphotericin-B, indomethacin, diclofenac, H2 antihistamines like ranitidine, cimetidine, phenobarbitone, rifampicin, allupurinol, febuxostat).
- History suggestive of allergy to azathioprine , cyclosporine.
- Absolute contraindications69 of azathioprine are severe infections, severly impaired hepatic or bone marrow function, pancreatitis, live vaccines, pregnancy and lactation.
- Patients with chronic kidney disease, uncontrolled hypertension, renal insufficiency, uncontrolled infections, cutaneous T-cell lymphoma, including mycosis fungoides, should not be given Cyclosporine70.
- Patients who are planning pregnancy.
Key Trial Info
Start Date :
December 6 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03250143
Start Date
December 6 2016
End Date
November 1 2017
Last Update
January 11 2018
Active Locations (1)
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1
PGIMER
Chandigarh, India, 160012