Health Condition 1: L500- Allergic urticaria Health Condition 2: null- diagnosis of CSU (EAACI), characterized by erythematous skin wheals accompanied by itching of unknown etiology will be recruited.
Conditions
Interventions
Intervention1: bepotastine besilate 20mg: bepotastine besilate is used in allaergic rhinitis and and allergic conjuctivitis.so we are trying to finf off label use of bepotastione in urticaria
Control
Sponsors
Dr E Gayathri
Eligibility
Inclusion criteria
Inclusion criteria: Male and female patients, aged 18-70 years old, with a diagnosis of CSU (EAACI), characterized by erythematous skin wheals accompanied by itching of unknown etiology will be recruited. Eligible patients should demonstrate Symptom score of >=2 (i.e. moderate to severe intensity UAS7 scores) during the baseline visit. Patients willing to give informed consent will be included.
Exclusion criteria
Exclusion criteria: Patients excluded from the study if they have any dermatological condition that could interfere with the efficacy evaluation (including eczema, contact dermatitis, atopic dermatitis, nummular eczema, autosensitization dermatitis, asteatotic eczema, lichen simplex chronicus, angioedema, , urticaria with known causes, urticaria related to thyroid disorders, urticaria pigmentosa, psoriasis, or ichthyosis o Known hypersensitivity to antihistamine, o Known autoimmune disorders, Hodgkins disease o Any clinically significant condition (cardiovascular, neurological, hepatic, renal, or malignant diseases), o Received ultraviolet light therapy before entry. o Similarly, patients who had received antihistamines (including H2 receptor antagonists) within 3 days, nonsteroidal anti-inflammatory drugs within 3 days, topical or systemic steroids within 4 weeks, astemizole within 6 weeks, ketotifen within 2 weeks, anti-Leukotrienes within 3 days. o Pregnant and lactating women. o Subject who is currently enrolled in another investigational drug study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is the change from baseline in mean weekly Urticaria activity score-7( i.e the sum of the daily UAS i.e.(sum of wheal & itching day and night time score) self evaluation scores of 7 individual days,which could range between 0 to 42 per week) after 4 weeks of treatment Timepoint: five time points-patients will be analyased during baseline and after every 7 days for 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset of action will be determined by comparing Bepotastine besilate with Levocetrizine by using participantâ??s daily scoring chart. C-reactive protein and Absolute Eosinophil count will be evaluated during the baseline visit and end of therapy for predicting the outcome of treatment with Bepotastine. 2.Chronic Urticaria quality of life questionnaire 3.Dermatology life quality index 4. Patients global assessment of their symptoms Timepoint: two time points-patients will be analyased during baseline and at the end of the study | — |
Countries
India
Contacts
Public ContactDr Gayathri E
Sri Ramachandra Medical College and Research Institute, Chennai
Outcome results
None listed