UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain
Title of the study (Brief title)	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	Yoshikazu Yonei
Organization	Doshisha University
Division name	Graduate School of Life and Medical Sciences
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	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.toukastress.jp/webj/article/2018/GS17-30.pdf?20180331
Results
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