Health Condition 1: null- patients with chronic spontaneous urticaria
Conditions
Interventions
Intervention1: olopatadine: antihistaminics used in condition urticaria.Dosage form -Tablet. Route of administration - Oral. Dose 5mg. Frequency - once a day at night.Duration of therapy - 6 weeks
Con
Sponsors
Indira Gandhi Government Medical college
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1) Those who were willing to participate in the study and comply with its procedures by signing a written informed consent. 2) Patients from Out-Patient Department (OPD) of dermatology between age group of 18 to 65 years of either sex. 3) History of urticarial wheal and/or angioedema for at least 3 days a week for 6 consecutive weeks with no obvious cause prior to inclusion in study. 4) Mean total symptom score (24 hour reflective) >= 3 at screening. This includes 1-5 number of wheals (score >= 1); at least a moderate severity of pruritus (score>=2). 5) Patients who were on any antihistamines except rupatidine and olopatadine were also included in the trail only after giving washout period of 7 days, irrespective of doses of the previous drugs. 6) Those who understood and agreed to adhere to the dosing and visit schedules, and agree to assess and record their symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1) History of asthma or any other disease requiring chronic use of inhaled or systemic corticosteroids. 2) Subjects with acute spontaneous urticaria or all physical and other subtypes of urticaria like aquagenic, cholinergic, contact and exercise induced urticaria 3) Had been unresponsive to antihistamine treatment in the past. 4) History of allergies to study medication or unable to tolerate antihistamines. 5) Use of study drug in the last 7 days prior to baseline and not willing to take washout period. 6) Pregnant female, nursing mothers. 7) Subjects with significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the following aims and objectives: 1) To compare efficacy of rupatadine and olopatadine in patients of CsU. A) Primary end point: To compare difference in mean total symptom score (MTSS) at baseline and six week.B) Secondary endpoint: a) To observe difference in average mean number of wheals (MNW), mean pruritus scale (MPS) and MTSS from baseline to end of one, three and six week.Timepoint: Six weeks study..patient will be followed at one, three and six week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point a) Average change from baseline to end of 6 weeks treatment period in subjects 1. 12 hour reflective mean Number of Wheals (MNW) 2. 12 hour reflective mean pruritus scale (MPS) interference of wheals with sleep b) To observe difference in scale for interference of skin condition with sleep (SIWS) between baseline and six week. Timepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactDr SUMIT WANKHEDE
Government Medical College nagpur
Outcome results
None listed