Rheumatoid arthritis
Conditions
Interventions
24 weeks, Brazilian propolis-containing test balls are taken 5 balls a day on a daily basis
24 consecutive weeks, placebo test balls are taken 5 balls a day on a daily basis
Sponsors
Center for Senile Degenerative Disorders (CSDD), Osaka City University Medical School
Shirahama Hamayu Hospital, Kitade Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) RA patients meeting the 2010 ACR / EULAR classification criteria (irrespective of disease duration) 2) Moderate disease activity (DAS 28 - ESR is greater than 3.2, less than or equal to 5.1) 3) After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will with sufficient understanding 4) Administration of biological products (bDMARDs) and antirheumatic drugs (csDMARDs) is constant over 12 weeks before intervention 5) The dose of NSAID and steroid (predonisolone equivalent 10 mg / day or less) dose is also constant for 12 weeks or more before consent acquisition 6) outpatient
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the difference of the change of DAS28-ESR (disease activity score 28-erthrocyte sedimentation rate) at week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTatsuya Koike
Osaka City University Medical School Center for Senile Degenerative Disorders (CSDD)
Outcome results
None listed