sefulness and safety of conventional and modified self-serum therapy in long standing generalised itch and wheals of ski
Phase 4
- Conditions
- Health Condition 1: null- All patients clinically diagnosed as ChronicUrticaria aged 18 yrs and above and not responding to a single daily dose of second generationantihistamine after 2 weeks of therapy
- Registration Number
- CTRI/2016/05/006907
- Lead Sponsor
- Medical College Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 64
Inclusion Criteria
All patients presenting with chronic urticaria aged above 18 years and symptoms not responding to a single daily dose of second generation antihistamine after 2 weeks of therapy.
Exclusion Criteria
Pregnant and lactating ladies
Immunosuppressed due to drug or disease
Allergy to Cetirizine
Concomitant systemic illness requiring treatment
Mental illness interfering with perception of urticarial symptoms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical effectiveness of subcutaneous autologous serum therapy versus <br/ ><br>conventional intramuscular serum therapy in cases of chronic urticaria <br/ ><br>1. By Urticaria Severity Score (USS) <br/ ><br>2. By Total Severity Score (TSS)Timepoint: Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
- Secondary Outcome Measures
Name Time Method A. Safety of two treatment arms <br/ ><br>1. By checklist for adverse events <br/ ><br>2. CDSCO ADR reporting form <br/ ><br>3. Laboratory investigations <br/ ><br>B. Quality of life in the two treatment arms by Dermatology Life Quality Index (DLQI)Timepoint: Baseline and at 8 weeks and 32 weeks after randomization