BeeDAI Trial

JRCT ID: jRCTs051180142

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rheumatoid Arthritis
• Date of first enrollment: 03/07/2018
• Target sample size: 80
• Study type: Interventional
• Intervention(s): 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 (508.5 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.

Outcome(s)

• 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.

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: < 70age old
• Gender: Female

Include 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

Exclude criteria

1.Patients who can not come to the examination on a regular basis
2.patients with undifferentiated arthritis
3.Patients taking propolis as a supplement 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

Related Information

• Primary Sponsor: Koike Tatsuya
• Secondary Sponsor: Matsumoto Yoshinari
• Source(s) of Monetary Support: Yamada research grant
• Secondary ID(s): UMIN000032149