BeeDAI Trial

INTERVENTION: Eighty female rheumatoid arthritis patients with moderate disease activity will be devided into 40 Brazilian propolis group (P group) and 40 placebo group (C group). Assignment is made by double‐blind randomization by stratified replacement block method with facilities in layers. Patients in P group ingest Brazilian propolis with 5 spheres per day (378 mg as propolis) and patients in group C ingest 5 balls of Brazilian propolis‐free placebo balls per day. Both dosing periods are 24 weeks. CONDITION: D001172 Rheumatoid Arthritis ; Rheumatoid Arthritis PRIMARY OUTCOME: The change of DAS28‐ESR (disease activity score 28‐ erythrocyte sedimentation rate) at week 24 after the administration of test food SECONDARY OUTCOME: 1)DAS28‐CRP (C‐reactive protein), SDAI (simplified disease activity index) and CDAI (clinical disease index) at week 12, 24 and 36.; 2)QOL (quality of life) evaluated by the change of the score by SF‐36 (short form 36) at week 24.; 3)The change of ADL (activity of daily living) evaluated by mHAQ (modified health assessment questionnaire) at week 12, 24 and 36.; 4)The change of sonographic total scale of hand and foot joint at week 12, 34 and 36.; 5)Adverse events requiring discontinuation of the test food up to 24 weeks after starting ingestion.; 6)Severe adverse events up to 36 weeks after starting ingestion.; 7)All adverse events up to 36 weeks after starting ingestion. INCLUSION CRITERIA: 1.Female 2.RA patients meeting the 2010 ACR / EULAR classification criteria (irrespective of disease duration) 3.Moderate disease activity (DAS 28 ‐ ESR is greater than 3.2, less than or equal to 5.1) 4.After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will with sufficient understanding. 5.Administration of biological products (bDMARDs) and antirheumatic drugs (csDMARDs) is constant over 12 weeks before intervention 6.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 7.Outpatient