Health Condition 1: null- Satisfactory
Conditions
Interventions
Intervention1: Group A (cyclosporine) & group B (azathioprine): Patients will be randomized into two groups A and B using computer generated random number tables, group A will receive Cyclosporine and
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 generatio
Sponsors
Nil
Eligibility
Inclusion 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
Exclusion criteria: 1. Patients giving history of fainting, bronchospasm during previous attacks of urticaria that is suggestive of anaphylaxis. 2. Urticaria 3. Age 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in urticaria activity score (UAS7) i.e decrease more than 75% from. baseline to week 12 (at end of treatment) within group A and B and comparison between corresponding groups. Timepoint: From baseline to the week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Change in outcome scoring scale (OSS) from baseline to week 12 within group A and B. b. Change in UAS7 and OSS from baseline to week 24 (end of follow-up) within group A and B. c. Change in ASST, APST, IgE levels from baseline to week 12 within group A and B. d. Comparison for the above mentioned parameters between group A and B. Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDr Yashdeep singh pathania
Pgimer chandigarh
Outcome results
None listed