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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023492
Receipt No. R000027063
Scientific Title A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effect of Daily Low molecular Chondroitin Sulfate Origosaccharides Ingestion for Improvements in Knee Joint Function
Date of disclosure of the study information 2016/08/05
Last modified on 2017/03/29

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Basic information
Public title A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effect of Daily Low molecular Chondroitin Sulfate Origosaccharides Ingestion for Improvements in Knee Joint Function
Acronym Effect of Daily Low molecular Chondroitin Sulfate Origosaccharides Ingestion for Improvements in Knee Joint Function
Scientific Title A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effect of Daily Low molecular Chondroitin Sulfate Origosaccharides Ingestion for Improvements in Knee Joint Function
Scientific Title:Acronym Effect of Daily Low molecular Chondroitin Sulfate Origosaccharides Ingestion for Improvements in Knee Joint Function
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinical usefulness of 12-week ingestion of Low molecular Chondroitin Sulfate Origosaccharides for improvements in knee joint function.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Japanese Knee Osteoarthritis Measure 4 weeks and 8 weeks after beginning ingestion of test meals
Key secondary outcomes VAS questionnaire for knee pain and skin condition, CRP and locomotive syndrome risk test,C2C, CP2,C2C/CP2 ratio

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of two capsules containing Low molecular Chondroitin Sulfate Origosaccharides (100 mg/day) daily for 8 weeks
Interventions/Control_2 Ingestion of two placebo capsules daily for 8 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
45 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects with knee joint pain.
2. Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria 1. Subjects who are under treatment and medication for osteoarthritis (knee, the base of the foot, elbow, shoulder, etc.).
2. Injured subjects with problems in daily life.
3. Subjects who are under treatment and medication of rheumatoid arthritis (RA) or subjects who are suspected to have RA (MMP-3>=121 ng/ml (men), MMP-3>=59.7 ng/ml (women)).
4. Subjects who are suspected to have secondary arthrosis (autoimmune disease, gout, bone fracture in the lower body, surgical history in the lower body, injury of ligament and meniscus, dislocation, congenital abnormality of joint function, etc.).
5. Subjects regularly take anticoagulants, antiplatelet agents or NSAIDs.
6. Subjects with serious cerebrovascular, cardiac, hepatic, renal, and / or gastrointestinal diseases, or affected with an infectious disease which is required to report to the authorities.
7. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
8. Subjects with unusually high and/or low blood pressure or abnormal hematological data.
9. Subjects with serious anemia.
10. Pre- or post-menopausal subjects having complaints of obvious physical changes.
11. Subjects who are at risk of having allergic reactions to drugs or foods (especially fish or wheat).
12. Subjects regularly take medicine, functional foods and/or supplements which would affect the joint function.
13. Heavy smokers, alcohol addicts or subjects with irregular lifestyle.
14. Subjects who donated either 400ml whole blood within 12 weeks (men) /16 weeks (women) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
15. Subjects who are pregnant or expected to be pregnant, or lactating during the study.
16. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial.
17. Any other medical reasons judged by the principal investigator.
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, Nishi-Nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Center of Health Information Science
Zip code
Address 59-2, N59-2, Nishi-Nopporo, Ebetsu, Hokkaido, 069-858ishi-Nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization Marukyou Suisan Co. Ltd
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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 05 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 21 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 30 Day
Last follow-up date
2016 Year 12 Month 21 Day
Date of closure to data entry
2017 Year 01 Month 24 Day
Date trial data considered complete
2017 Year 01 Month 31 Day
Date analysis concluded
2017 Year 03 Month 24 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 04 Day
Last modified on
2017 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027063

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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