UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032149 |
|---|---|
| Receipt number | R000036673 |
| Scientific Title | Double blinded randomized controlled trial to reveal the effects of Brazilian propolis intake to rheumatoid arthritis disease activity index |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2020/02/02 12:55:55 |
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Basic information
Public title
Double blinded randomized controlled trial to reveal the effects of Brazilian propolis intake to rheumatoid arthritis disease activity index
Acronym
BeeDAI
Scientific Title
Double blinded randomized controlled trial to reveal the effects of Brazilian propolis intake to rheumatoid arthritis disease activity index
Scientific Title:Acronym
BeeDAI
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate whether rheumatoid arthritis (RA) disease activity is suppressed by taking propolis which is a resin mixture gathered from a plant source such as tree buds and sap by honeybee to a patient with RA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the difference of the change of DAS28-ESR (disease activity score 28-erthrocyte sedimentation rate) at week 24.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
24 weeks, Brazilian propolis-containing test balls are taken 5 balls a day on a daily basis
Interventions/Control_2
24 consecutive weeks, placebo test balls are taken 5 balls a day on a daily basis
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key 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
Key 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
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Koike |
Organization
Osaka City University Medical School
Division name
Center for Senile Degenerative Disorders (CSDD)
Zip code
545-8585
Address
Abenoku Asahimachi 1-4-3, Osaka 5454-8585, Japan
TEL
06-6646-6010
tatsuya@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Koike |
Organization
Osaka City University Medical School
Division name
Center for Senile Degenerative Disorders (CSDD)
Zip code
545-8585
Address
Abenoku Asahimachi 1-4-3, Osaka 5454-8585, Japan
TEL
06-6646-6010
Homepage URL
tatsuya@med.osaka-cu.ac.jp
Sponsor or person
Institute
Center for Senile Degenerative Disorders (CSDD), Osaka City University Medical School
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shirahama Hamayu Hospital, Kitade Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Hospital Certified Review Board
Address
Abenoku Asahimachi 1-5-7, Osaka 5454-8585, Japan
Tel
06-6645-2121
ethics@med.osaka-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs051180142
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪市立大学医学部付属病院〔大阪府）、白浜はまゆう病院〔和歌山県）、北出病院〔和歌山県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
80
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 29 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 07 | Day |
Last modified on
| 2020 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036673
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