Health Condition 1: null- H1 antihistamine resistant chronic spontaneous urticaria Health Condition 2: L501- Idiopathic urticaria
Conditions
Interventions
Intervention1: Group A( Experimental group): Methotrexate- route of administration- oral. methotrexate shall be started at a test dose of 2.5 mg and after every 2 weeks the dose shall be increased by
Sponsors
JIPMER intramural research fund
Eligibility
Inclusion criteria
Inclusion criteria: Patients diagnosed with H1 antihistamine resistant chronic spontaneous urticaria,characterized by the presence of continuous or recurrent wheals with or without angioedema of greater than 6 months duration,not responding to licensed doses of cetirizine.
Exclusion criteria
Exclusion criteria: 1.Subjects on medications other than antihistamines since past 3 months 2.Physical urticaria alone and urticarial vasculitis. 3.Pregnant and lactating women 4.Pre-existing hepatic and renal disease 5.Other inflammatory skin diseases like psoriasis, lichen planus, vitiligo, pityriasis rubra pilaris, erythroderma 6.Known case of alcoholism 7.Severe hematologic abnormalities (white blood cell count (WBC) 8.Patients contemplating conceptions 9.Active infectious disease or evidence of latent tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the efficacy of weekly methotrexate in addition to licensed dose of antihistamines in comparison to standard treatment with updosing of antihistamines on the clinical outcome of patients with CSU (twice daily urticaria activity score over 7 days (UAS7TD), urticaria control test (UCT), urticaria severity score(USS) and chronic urticaria quality of life (CU-Q2OL). 2.To compare the profile of side effects between the two groups. Timepoint: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| compare duration of remission and frequency of relapse after stopping the interventions in the two armsTimepoint: 18 months;To assess the effect of the interventions on the changes in the serum levels of biomarkers of CSU (Interleukin-6 and D-dimer).Timepoint: 18 months;To assess the effect of the interventions on the clinical outcome of patients with and without chronic autoimmune urticaria.Timepoint: 18 months;To compare the time taken for complete symptom control after receiving the intervention between the two groups.Timepoint: 18 months;To determine the optimal dose and duration of methotrexate therapy that would result in complete symptom control in CSU.Timepoint: 18 months | — |
Countries
India
Contacts
Public ContactDr Malathi M
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed