UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021635 |
|---|---|
| Receipt number | R000024950 |
| Scientific Title | Study for theraputic effects of soy been peptides on rheumatoid arthritis-dose response study. |
| Date of disclosure of the study information | 2016/03/27 |
| Last modified on | 2016/03/27 12:33:06 |
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Basic information
Public title
Study for theraputic effects of soy been peptides on rheumatoid arthritis-dose response study.
Acronym
Dose response study for soy been peptide in rheumatoid arthritis
Scientific Title
Study for theraputic effects of soy been peptides on rheumatoid arthritis-dose response study.
Scientific Title:Acronym
Dose response study for soy been peptide in rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dose response study for theraputic effect of soy been peptide in patinets with rheumatoid arthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inhibitory effects of soy been peptide on number of tender joints, sowollen joints, and anti-pain effect.
Key secondary outcomes
Inbitory effects of soy been peptide on inflammation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patients with rheumatoid arthritis were orally treated with soy been peptide (4g/day) for 8 weeks.
Interventions/Control_2
Patients with rheumatoid arthritis were orally treated with soy been peptide (8g/day) for 8 weeks.
Interventions/Control_3
Patients with rheumatoid arthritis were orally treated with placebo peptide everday for 8 weeks.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Out patients with rheumatoid arthritis.
Key exclusion criteria
Patients with malignant tumor, or other severe diseases. Hospitalized patients.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Yudo |
Organization
St. Marianna University School of Medicine
Division name
Institute of Medical Science
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki City 2168512.
TEL
0449778111
yudo@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Yudo |
Organization
St. Marianna University School of Medicine
Division name
Institute of Medical Science
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki City 2168512, Japan.
TEL
0449778111
Homepage URL
yudo@marianna-u.ac.jp
Sponsor or person
Institute
Institute of Medical Science, St. Marianna University school of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Fuji Seiyu, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 27 | 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
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 27 | Day |
Last modified on
| 2016 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024950
