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临床试验/CTRI/2017/08/009213
CTRI/2017/08/009213进行中(未招募)1 期

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

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试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 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.

排除标准

  • 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.
  • 11. Patients with chronic kidney disease, uncontrolled hypertension, renal insufficiency,
  • uncontrolled infections, cutaneous T-cell lymphoma, including mycosis fungoides, should
  • not be given Cyclosporine70.
  • 12. Patients who are planning pregnancy.

研究者

发起方
il

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