UMIN-CTR Clinical Trial

Basic information
Public title	Clinical studies aimed to confirm the arthritis reduce the effect of AlcoCare HG-P intake
Acronym	AlcoCare HG-P test
Scientific Title	Clinical studies aimed to confirm the arthritis reduce the effect of AlcoCare HG-P intake
Scientific Title:Acronym	AlcoCare HG-P test
Region	Japan

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

Objectives
Narrative objectives1	To confirm the arthritis reducing effect of before and after ingesting the AlcoCare HG-P
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	.JKOM(VAS including)knee joint pain questionnaire .JOA survey .Evaluation of flexion and extension degree of knee joint range of motion inspection by the goniometer .High sensitivity CRP .including doctors findings and evaluation (the subject diary)
Key secondary outcomes	.safety assessment .Blood,blood pressure,body weight Safety:vital signs,hematology,blood biochemistry,urinalysis,adverse events,and other associated symptoms .Subject diary

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Supplement(3capsule a day)
Interventions/Control_2	Placebo Supplement(3capsule a day)
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	40 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Age:40 years of age or 69 years of following a healthy Japan's men and women(at the time of obtaining informed consent) 2.hospitalization,outpatient:foreign 3.knee joint range of motion test persons evaluated in(goniometer)is bad 4.JKOM knee joint pain questionnaire is based on the person of low value(in principle 45 or less points) 5.JOA score is used as a reference person(with the exception of 70 points or more but 100 points)highs 6.Ability to consume test food for 12 weeks 7.If you are doing diet therapy or exercise therapy,those who do not change during the examination period 8.Those who can obtain written consent
Key exclusion criteria	1.Persons who have excessive smoking or drinking habits 2.Alcohol or drug addiction 3.Those who performed knee surgery in the past 4.Those who need hospitalization and treatment due to knee joint pain 5.Persons who have received medical treatment(massage or electric therapy)at the medical institution within the past two weeks and are planned to complete the examination 6. Person who regularly uses general commercial externally applied agent(vantelin etc.),knee supporter,taping,poultice etc,for knee joint pain 7.While taking drugs for treatment of diseases,or those using injections,suppositories,etc. 8.Persons who have chronic diseases or disorders of liver,biliary tract,digestive system,cardiovascular system,respiratory system,kidney,urinary system,psychosis,nervous system,and blood system 9.Persons with arrhythmia and advanced anemia 10.Those who have the possibility of major changes in lifestyle during the examination period(including overseas trips) 11.Those who may be pregnant or may be pregnant,and those who are breastfeeding 12.One who has participated in other clinical trials within one month before acquiring consent or who is currently participating in other clinical trials 13.Person who is judged by the examination responsible physician or exam sharing doctor to increase the risk to the research subject by the examination or judge that there is a possibility that sufficient data can not be obtained
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Hokazono
Organization	Sanwa Shurui Co.,Ltd.
Division name	Food Division Functionality Laboratory
Zip code	879-0495
Address	Yamamoto 2231-1 Usa City, Oita Perfecture
TEL	(0978)33-3844
Email	hokazono-h@kokuzo.co.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Hokazono
Organization	Sanwa Shurui Co.,Ltd.
Division name	Food Division Functionality Laboratory
Zip code	879-0495
Address	Yamamoto 2231-1 Usa City, Oita Perfecture
TEL	(0978)33-3844
Homepage URL
Email	hokazono-h@kokuzo.co.jp

Sponsor
Institute	Clinical Creative Corporation
Institute
Department

Funding Source
Organization	Sanwa Shurui Co.,Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Institutions Sapporo Yuurinokai Hospital Clinical Trials Committee
Address	Kita-ku, Sapporo-shi Hokkaido Hokkaido 11 chome 186
Tel	011-771-1501
Email	info@yurinokai.jp

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	医療法人社団　札幌百合の会病院 Medical Corporation Association Sapporo Yurinokai Hospital

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 14 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	42
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	2018 Year 10 Month 17 Day
Date of IRB	2019 Year 01 Month 23 Day
Anticipated trial start date	2019 Year 02 Month 14 Day
Last follow-up date	2019 Year 05 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 21 Day
Last modified on	2019 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040567