sefulness and safety of self serum therapy in long-standing generalised itch and wheals of ski
Phase 4
- Conditions
- Health Condition 1: null- Chronic urticaria
- Registration Number
- CTRI/2012/12/003204
- Lead Sponsor
- Institutional
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Adult patients ( >18 yrs) of either sex suffering from chronic urticaria attending the Dermatology out-patient department of a tertiary care teaching hospital in Eastern India were included
Exclusion Criteria
Pregnant, lactating women, patients suffering from immunosuppression due to drug or disease, advanced diseases of vital organs, inability to come for weekly follow-ups, addicted to alcohol or other substance abuse, machinery operators, vehicle drivers and in whom sleep/wake cycle alteration could be an issue were excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measures for effectiveness were Urticaria activity score (UAS )and Urticaria total severity score (TSS)Timepoint: baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 24 weeks following randomization.
- Secondary Outcome Measures
Name Time Method Dermatologic Life quality Index(DLQI)Timepoint: baseline, 8 and 24 weeks following randomisation;safety parameters: <br/ ><br>1. Spontaneously reported adverse events by patients <br/ ><br>2. Adverse events noted by investigators during clinical examinationsTimepoint: baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 24 weeks following randomization.;Safety parameters: <br/ ><br>routine lab parameters (Haematocrit, LFT, Serum urea creatinine, FBS)Timepoint: baseline, 8 weeks following randomisation (end of intervention);The secondary effectiveness parameters were Patientsâ?? global assessment of disease activity improvement and Physiciansâ?? global assessment of disease activity improvementTimepoint: baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 24 weeks following randomization.