A trial comparing psychological therapy with steroids in treatment of chronic urticaria patients

Phase 4

Conditions: Health Condition 1: L501- Idiopathic urticaria

Registration Number: CTRI/2019/07/020194

Lead Sponsor: Department of Science and Technology Science and Engineering Research Board DSTSERB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Inclusion criteria for cases (serum (154 cases) and skin (20 samples):

1. Consecutive consenting patients of both gender aged 18-60 years, attending the â??Chronic Urticaria clinicâ?? of the dermatology OPD of JIPMER diagnosed with chronic spontaneous urticaria, characterized by the presence of continuous or recurrent weals with or without angioedema of greater than 6 weeks duration.

Inclusion criteria for controls (serum)(154 controls):

1. Age and gender matched healthy subjects

Inclusion criteria for controls (skin): (20 samples)

1.Discarded skin samples obtained for split thickness graft for treatment of ulcers

Exclusion Criteria

Exclusion criteria for both cases (154 cases) and controls (154 controls):

1.Subjects not on any medication for the past three months prior to recruitment other than antihistamines

2.Physical urticaria and urticarial vasculitis

3.Pregnant and lactating women

4.Pre-existing endocrine disorders

5.Pre-existing psychiatric illness

6.Pre-existing chronic illness like diabetes, hypertension, hepatic and renal disease, connective tissue diseases, malignancies

7.Other inflammatory skin diseases like psoriasis, lichen planus, vitiligo, pityriasis rubra pilaris, erythroderma

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of intervention among CSU patients (154) on clinical outcome: <br/ ><br>1.stress scores (Daily Hassles and Uplifts Scale-Revised (DHUS-R);Presumptive Stressful Life Events Scale (PSLE);Perceived stress scale (PSS)-10 item); <br/ ><br>2.disease activity and disease severity scores (Urticaria activity score (sum score of 7 consecutive days) (UAS 7);Urticaria severity score (USS);Urticaria control test (UCT; <br/ ><br>3.quality of life scores(Chronic urticaria- Quality of life (CU-Q2oL); <br/ ><br>4. medication usageTimepoint: At recruitment; Follow up at 1,2,3 months

Secondary Outcome Measures