Unique ID issued by UMIN | UMIN000026460 |
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Receipt number | R000030192 |
Scientific Title | A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain |
Date of disclosure of the study information | 2017/03/10 |
Last modified on | 2019/01/28 18:28:20 |
A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain
A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain
A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain
A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain
Japan |
N/A (healthy adults)
Adult |
Others
NO
The objectives of this study are to verify the efficacy and safety of INJUV ingestion in individuals with knee and low back pain.
Safety,Efficacy
[1]Improvement of knee pain (motion range evaluation of knee joints, JCOM, WOMAC)(2W, 4W, 6W, 8W)
[2]Improvement of low back pain (JLEQ)(2W, 4W, 6W,8W)
[1]Improvement of QOL(Anti-Aging QOL Common Questionnaire)
[2]Improvement of inflammation(hs-CRP)
[3]Anti-glycation(Pentosidine)
[4]Safety(Blood biochemistry etc.)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
Oral ingestion of the test product (8 weeks)
55 | years-old | <= |
70 | years-old | > |
Male and Female
[1]Japanese males and females aged 55-69 years
[2]Healthy individuals not receiving any medical disease treatment
[3]Individuals with knee and/or low back pain in daily life
[4]Individuals voluntarily join the study with written informed consent
[5]Individuals who can visit study site and receive examinations on designated days
[6]Individuals judged appropriate to join this study by principal investigators
[1]Individuals receiving medical drugs for treatment of chronic diseases
[2]Individuals receiving outpatient care (except for bonesetters, chiropractors, massagers) for knee and/or low back pain
[3]Individuals with history of palliative therapy (hyaluronic acid, steroid injection, etc.) or surgical therapy (arthroscopic osteotomy, artificial joint, bolt fixation surgery, etc.)on knees and/or waist
[4]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders
[5]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc.
[6]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.)
[7]Individuals with history of gastrointestinal disorders except for appendicitis
[8]Individuals with inflammatory disorders such as chronic sinusitis, periodontal disease, bronchitis, etc.
[9]Individuals with >=30.0kg/m2 BMI
[10]Individuals donated blood >200ml in past 1 month or >400ml in past 3 months
[11]Individuals with serious anemia
[12]Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs
[13]Individuals continually consumed health foods that may interfere the study results (especially glucosamine, chondroitin, etc.) in the past 3 months except for general nutritional supplements
[14]Individuals with alcohol intake exceeding 40mg/day,200mg/week as ethanol volume
[15]Smokers or ex-smokers within one year after quitting
[16]Individuals who may significantly change exercise habit or lifestyle during the study period
[17]Individuals participating or planning to join the other clinical investigations during the study period
[18]Pregnant or lactating women (expected, desired inclusive)
[19]Individual with potential conflict of interests
etc.
12
1st name | |
Middle name | |
Last name | Yoshikazu Yonei |
Doshisha University
Graduate School of Life and Medical Sciences
1-3 Tatara Miyakodani Kyotanabe City Kyoto, 610-0394, Japan
0774-65-6394
yyonei@mail.doshisha.ac.jp
1st name | |
Middle name | |
Last name | Toshiyasu Tamura |
TES Holdings Co., Ltd.
Department of Clinical Trial
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
03-6801-8480
info@tes-h.co.jp
Anti-Aging Bank Co.,Ltd.
LAIMU Corporation
Profit organization
NO
2017 | Year | 03 | Month | 10 | Day |
Published
http://www.toukastress.jp/webj/article/2018/GS17-30.pdf?20180331
Completed
2017 | Year | 02 | Month | 24 | Day |
2017 | Year | 03 | Month | 08 | Day |
2017 | Year | 03 | Month | 08 | Day |
2019 | Year | 01 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030192
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