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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026460
Receipt No. 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

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Basic information
Public title A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain
Acronym A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain
Scientific Title A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain
Scientific Title:Acronym A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain
Region
Japan

Condition
Condition N/A (healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of this study are to verify the efficacy and safety of INJUV ingestion in individuals with knee and low back pain.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [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)
Key secondary outcomes [1]Improvement of QOL(Anti-Aging QOL Common Questionnaire)
[2]Improvement of inflammation(hs-CRP)
[3]Anti-glycation(Pentosidine)
[4]Safety(Blood biochemistry etc.)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral ingestion of the test product (8 weeks)
Interventions/Control_2
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
55 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria [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
Key exclusion criteria [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.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Yonei
Organization Doshisha University
Division name Graduate School of Life and Medical Sciences
Zip code
Address 1-3 Tatara Miyakodani Kyotanabe City Kyoto, 610-0394, Japan
TEL 0774-65-6394
Email yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyasu Tamura
Organization TES Holdings Co., Ltd.
Division name Department of Clinical Trial
Zip code
Address 6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL 03-6801-8480
Homepage URL
Email info@tes-h.co.jp

Sponsor
Institute Anti-Aging Bank Co.,Ltd.
Institute
Department

Funding Source
Organization LAIMU Corporation
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
2017 Year 03 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.toukastress.jp/webj/article/2018/GS17-30.pdf?20180331
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
2017 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 08 Day
Last modified on
2019 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030192

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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