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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035610
Receipt No. R000040567
Scientific Title Clinical studies aimed to confirm the arthritis reduce the effect of AlcoCare HG-P intake
Date of disclosure of the study information 2019/02/14
Last modified on 2019/07/24

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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/ctr_e/ctr_view.cgi?recptno=R000040567

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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