Comparison of Methotrexate with Cetirizine versus increasing doses of cetirizine in patients with chronic urticaria.
- Conditions
- Health Condition 1: null- H1 antihistamine resistant chronic spontaneous urticariaHealth Condition 2: L501- Idiopathic urticaria
- Registration Number
- CTRI/2017/10/009998
- Lead Sponsor
- JIPMER intramural research fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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) < 3500/mm3, platelet count <100 000/mm3)
8.Patients contemplating conceptions
9.Active infectious disease or evidence of latent tuberculosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). <br/ ><br>2.To compare the profile of side effects between the two groups. <br/ ><br>Timepoint: 18 months
- Secondary Outcome Measures
Name Time Method 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