Akamuku for seasonal allergic rhinitis; singlecenter double blind randomized control trial
Not Applicable
- Conditions
- seasonal allergic rhinitis
- Registration Number
- JPRN-UMIN000012996
- Lead Sponsor
- Department of Otolaryngology Head and Neck Surgery, Ehime University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Patients are excluded if they had received intranasal or oral prophylactic therapy that season; had known serious renal, cardiac, or hepatic disease; were pregnant or lactating; or had asthma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary trial outcomes were change in symptoms and change in need for medication between baseline and 4 week after treatment. We assessed symptoms by using the disease-specific Japan Rhinitis Quality of Life Questionnaire (JRQLQ). The JRQLQ has 24 questions in 8 domains of nose and eye symptoms, usual daily activities, outdoor activities, social functioning, sleep problems, general physical problems and emotional function, and the overall QOL. Each questions evaluate symptom on a five-point scale (0 for no symptoms, 1 for mild, 2 for moderately severe, 3 for severe and 4 for very severe symptoms). Medication need was measured using an rescue medication score (RMS), comprising the weekly sum of daily assessments (fexofenadine 60 mg/d, or equivalent [1 point]; fexofenadine 120 mg/d, or equivalent [2 points]; and any form of nasal steroids for SAR [2 points]) (daily range, 0 to 4; weekly range, 0 to 28).
- Secondary Outcome Measures
Name Time Method Secondary trial outcomes were change in symptoms and change in need for medication between baseline and 8, 12 week after treatment.