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Assessing and comparing efficacy of cyclosporine versus azathioprine in CR

Phase 1
Conditions
Health Condition 1: null- Satisfactory
Registration Number
CTRI/2017/08/009213
Lead Sponsor
il
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
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.

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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