Double blinded randomized controlled trial to reveal the effects of Brazilian propolis intake to rheumatoid arthritis disease activity index
Not Applicable
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-UMIN000032149
- Lead Sponsor
- Center for Senile Degenerative Disorders (CSDD), Osaka City University Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who can not come to the examination on a regular basis 2) patients with undifferentiated arthritis 3) Patients taking propolis within 4 weeks before consent acquisition 4) Patients with significant obesity (BMI 30 or more) 5) Patients with abnormalities in liver function (AST or ALT more than 3 times higher than normal upper limit) 6) Patients with abnormal renal function (BUN 25 mg / dL or more or serum creatinine 2.0 mg / dL or more) 7) Patients who are pregnant or lactating 8) Patients with food allergy history 9) Others, patients judged by doctors as inappropriate as subjects
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the difference of the change of DAS28-ESR (disease activity score 28-erthrocyte sedimentation rate) at week 24.
- Secondary Outcome Measures
Name Time Method 1) DAS 28-CRP (C-reactive protein), SDAI simplified disease activity index), CDAI (clinical disease activity index) at 12 weeks, 24 weeks, and 36 weeks 2) QOL (quality of life) (SF-36) at 24 weeks 3) ADL (activity of daily living): mHAQ (modified health assessment questionnaire) at 12 weeks, 24 weeks, and 36 weeks 4) joint echo findings (scale change) at 12 weeks, 24 weeks, and 36 weeks 5) Adverse events requiring discontinuance of the test food up to 24 weeks 6) Serious adverse events up to 36 weeks after ingestion 7) All adverse events up to 36 weeks after starting ingestion