UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035610 |
|---|---|
| Receipt number | 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 11:03:29 |
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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
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
hokazono-h@kokuzo.co.jp
Sponsor or person
Institute
Clinical Creative Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040567
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
