UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027901 |
|---|---|
| Receipt number | R000031968 |
| Scientific Title | Examination on an influence of a test food product on knee joint pain |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2018/02/01 10:26:59 |
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Basic information
Public title
Examination on an influence of a test food product on knee joint pain
Acronym
Examination on an influence of a test food product on knee joint pain
Scientific Title
Examination on an influence of a test food product on knee joint pain
Scientific Title:Acronym
Examination on an influence of a test food product on knee joint pain
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine an influence of a test food product on knee joint pain by selecting males and females of Japanese nationality aged 40 and over, below 75 who are aware of knee pain but have not received orthopedic treatment as subjects and assigning them to take the test food product on a continuous basis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
JKOM survey
Key secondary outcomes
VAS survey
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
6-week intake of the test food
Interventions/Control_2
6-week intake of the placebo food
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Subjects giving written informed consent
2.To examine an influence of a test food product on knee joint pain by selecting males and females of Japanese nationality aged 40 and over, below 75 who are aware of knee pain but have not received orthopedic treatm
Key exclusion criteria
1.Currently seeing a doctor for treatment of knee joint pain
2.Currently in treatment with medication
3.Presence or previous history of allergy to medication and/or food (especially, shrimps and crabs)
4.Presence or previous history of a severe disorder(s) such as diabetes, a circulatory disease, a hepatic disease, a renal disease, or a cardiac disease
5.Currently in treatment of rheumatism
6.Previous history of knee surgery
7.Plan to undergo medical treatment on knees during the study
8.Underwent an intraarticular injection of hyaluronic acid within two weeks before the selection or intraarticular injection of steroids within three months before the selection
9.Diagnosed with a bone or joint-related diseases such as a bone fracture or a sprain within the past three months
10.Regular intake of a health food product that contains hyaluronic acid, glucosamine, chondroitin sulfate, quercetin glycoside, vitamin D, or amino-acid formulation, and the intention of consuming the product during the study
11.Regular intake of medication with an influence on the evaluation of this study (particularly, a pharmaceutical product that contains glucosamine, chondroitin sulfate, vitamin D, or amino-acid formulation, or a pharmaceutical product for treatment of osteoporosis)
12.Regular use of an assistive cane
13.Regular intake of warfarin (product names: Warfarin, Warin, Arefarin, Warfarin, etc.) for treatment of cerebral infarction, a cardiac disease, or the like
14.Nursing or pregnant, or desired to become pregnant during the study
15.Presence or previous history of psychiatric visits for depression, a sleep disorder, etc.
16.Determined by the investigator to be unsuitable for enrollment in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ochitani Daisuke |
Organization
Clinical Development Division
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
ochitani@huma-c.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ochitani Daisuke |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
Homepage URL
ochitani@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
MYCARE Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 06 | Month | 26 | 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
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 | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 25 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 25 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2018 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031968
