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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023811
Receipt No. R000027431
Scientific Title A knee collagen support study
Date of disclosure of the study information 2016/08/29
Last modified on 2018/04/10

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Basic information
Public title A knee collagen support study
Acronym A knee collagen support study
Scientific Title A knee collagen support study
Scientific Title:Acronym A knee collagen support study
Region
Japan

Condition
Condition Heslthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An objection of the study is to examine influences of a test food product on flexibility, discomfort, and mobility of knee joints after males and females aged over 40 and below 75, who feel discomfort in knee joints but do not undergo treatment in orthopedics, continuously take the test food product for 12 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes JOA
JKOM
VAS
hs-CRP
Key secondary outcomes

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 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Continuous intake of the test food product for 12 weeks.
Interventions/Control_2 Continuous intake of the placebo food product for 12 weeks.
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
40 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria 1.Japanese males and Japanese females aged over 40 and below 75.
2.Presence of discomfort in knee joints.
3.Grade 0 to I in categories K to L in the X-ray examination during selection.
4.Score of 25 or lower on the JOA evaluation of "pain and walking ability" during selection.
Key exclusion criteria 1.Currently seeing a doctor for treatment of a knee joint pain.
2.Currently in treatment with medication.
3.Diagnosed with Hyperuricemia with possible occurrence of a gout attack.
4.Diagnosed with severe disorders such as diabetes, a circulatory disease, a hepatic disease, a renal disease and a cardiac disease, or previous history of any of those.
5.Positive result in a rheumatoid factor test prior to the intake or a possibility of gaining a pain caused by rheumatism.
6.Prior history of a knee surgery or necessity of a knee surgery.
7.Plan to undergo medical treatment on knees during a study period.
8.Underwent a hyaluronic acid injection within two weeks before the selection or a steroid injection within three months before the selection.
9.Diagnosed with bone or joint-related diseases such as a fracture and a sprain within the past three months.
10.Regular intake of health food that contains hyaluronic acid, glucosamine, chondroitin sulfuric acid, quercetin glycoside, vitamin D, or an amino-acid drug, and the intention of consuming the health food during the study period.
11.Regular intake of a pharmaceutical product with an influence on the evaluation of the study (particularly, a pharmaceutical product that contains glucosamine, chondroitin sulfuric acid, vitamin D or an amino-acid drug, or a pharmaceutical product for treatment of osteoporosis).
12.Regular use of a cane.
13.Regular intake of warfarin (product names: Warfarin, Warin, Arefarin, Warfarin K, etc.).
14.Allergic reaction to a food product or a drug.
15.Having the potential to become pregnant during the study or currently pregnant (including a possibility of being pregnant) or nursing.
16.Determined by the investigator or the subinvestigator to be unsuitable for enrollment in this study.
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitada Hira
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address RBM hamamatsucho Bldg.9F,1-27-12 Hamamatsucho,Minato-ku,Tokyo
TEL 03-3431-1260
Email hira@huma-c.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitada Hira
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address RBM hamamatsucho Bldg.9F,1-27-12 Hamamatsucho,Minato-ku,Tokyo
TEL 03-3431-1260
Homepage URL
Email hira@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Wellvenus Corp
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 医療法人社団幸和会 幸和クリニック(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 29 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
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 29 Day
Last follow-up date
2016 Year 11 Month 26 Day
Date of closure to data entry
Date trial data considered complete
2016 Year 12 Month 30 Day
Date analysis concluded
2017 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2018 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027431

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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