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Clinical Trials/CTRI/2017/08/009213
CTRI/2017/08/009213
Active, not recruiting
Phase 1

A randomized study to assess and compare the efficacy of cyclosporine versus azathioprine in the treatment of chronic refractory urticaria.

il0 sites0 target enrollmentTBD

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Health Condition 1: null- Satisfactory
Sponsor
il
Status
Active, not recruiting
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

Sponsor
il

Eligibility Criteria

Inclusion Criteria

  • 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), given for at least three consecutive months and requiring repeated courses of oral corticosteroids. There is no strict number of oral corticosteroids intake courses before the patient can be labeled as chronic refractory urticaria.

Exclusion Criteria

  • 1\. Patients giving history of fainting, bronchospasm during previous attacks of urticaria that is suggestive of anaphylaxis.
  • 2\. Urticaria \< 6 weeks.
  • 3\. Age \<18 years.
  • 4\. Physical and pressure urticaria.
  • 5\. Urticarial vasculitits.
  • 6\. Pregnant and lactating patients.
  • 7\. Cataract, hepatic or renal diseases, severe infections,poorly controlled hypertension
  • 8\. Concomitant intake of drugs like nephrotoxic drugs (gentamycin, vancomycin, amphotericin\-B, indomethacin, diclofenac, H2 antihistamines like ranitidine, cimetidine, phenobarbitone, rifampicin, allupurinol, febuxostat).
  • 9\. History suggestive of allergy to azathioprine , cyclosporine.
  • 10\. Absolute contraindications69 of azathioprine are severe infections, severly impaired hepatic or bone marrow function, pancreatitis, live vaccines, pregnancy and lactation.

Outcomes

Primary Outcomes

Not specified

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