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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021635
Receipt No. 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

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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
Email 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
Email yudo@marianna-u.ac.jp

Sponsor
Institute Institute of Medical Science, St. Marianna University school of Medicine.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024950

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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