Unique ID issued by UMIN | UMIN000023492 |
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Receipt number | 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 17:41:48 |
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
Effect of Daily Low molecular Chondroitin Sulfate Origosaccharides Ingestion for Improvements in Knee Joint Function
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
Effect of Daily Low molecular Chondroitin Sulfate Origosaccharides Ingestion for Improvements in Knee Joint Function
Japan |
Healthy adults
Adult |
Others
NO
To investigate the clinical usefulness of 12-week ingestion of Low molecular Chondroitin Sulfate Origosaccharides for improvements in knee joint function.
Safety,Efficacy
Confirmatory
Pragmatic
Japanese Knee Osteoarthritis Measure 4 weeks and 8 weeks after beginning ingestion of test meals
VAS questionnaire for knee pain and skin condition, CRP and locomotive syndrome risk test,C2C, CP2,C2C/CP2 ratio
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Food |
Ingestion of two capsules containing Low molecular Chondroitin Sulfate Origosaccharides (100 mg/day) daily for 8 weeks
Ingestion of two placebo capsules daily for 8 weeks
45 | years-old | <= |
70 | years-old | > |
Male and Female
1. Subjects with knee joint pain.
2. Subjects who agree to participate in the current study with a written informed consent.
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.
54
1st name | |
Middle name | |
Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Department of Medical Management and Informatics
59-2, Nishi-Nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | |
Middle name | |
Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Center of Health Information Science
59-2, N59-2, Nishi-Nopporo, Ebetsu, Hokkaido, 069-858ishi-Nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
Marukyou Suisan Co. Ltd
Profit organization
NO
北海道情報大学 保健センター(北海道)
2016 | Year | 08 | Month | 05 | Day |
Unpublished
Completed
2016 | Year | 07 | Month | 21 | Day |
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 12 | Month | 21 | Day |
2017 | Year | 01 | Month | 24 | Day |
2017 | Year | 01 | Month | 31 | Day |
2017 | Year | 03 | Month | 24 | Day |
2016 | Year | 08 | Month | 04 | Day |
2017 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027063
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