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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043053
Receipt No. R000049151
Scientific Title The efficacy evaluation of the dietary supplement on movement of the knee joint and walking function
Date of disclosure of the study information 2021/01/20
Last modified on 2021/04/06

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Basic information
Public title The efficacy evaluation of the dietary supplement on movement of the knee joint and walking function
Acronym The efficacy evaluation of the dietary supplement on movement of the knee joint and walking function
Scientific Title The efficacy evaluation of the dietary supplement on movement of the knee joint and walking function
Scientific Title:Acronym The efficacy evaluation of the dietary supplement on movement of the knee joint and walking function
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy of ingestion of the dietary supplement containing proteoglycan for 12 weeks on movement of the knee joint and walking function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Timed Up & Go Test
6-minute walking
Key secondary outcomes JKOM
Tinetti falls efficacy scale
Two-step test
Knee Extension Force
30-s chair-stand test

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 Ingestion of test food containing proteoglycan for 12 weeks
Interventions/Control_2 Ingestion of placebo for 12 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Males and females aged 40 and over
(2) Subjects who are judged not to need to be treated for their knees by orthopedist
(3) Subjects who have fear of falling
(4) Subjects with long seconds on Timed Up & Go Test
Key exclusion criteria Subjects
(1) who are suspected gouty attack with hyperuricemia
(2) who have positive rheumatoid factors on the screening test or may have rheumatic pain
(3) who have performed arthroplasty on the joints or need it
(4) who regularly take health food which may affect joints or muscles
(5) who take medicine regularly
(6) who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test
(7) who get an intense exercise to make excessive load on the joints
(8) who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test
(9) who regularly use a stick or supporter
(10) who periodically conduct actions that may affect the evaluation of effectiveness
(11) who are under treatment of diseases on the joints
(12) who have severe diseases or have a history of such serious disorders
(13) who are under treatment or have a history of mental diseases
(14) who have unsteady lifestyle or who work manual labor
(15) who drink a lot
(16) who have possibilities for emerging allergy onset related to the study
(17) who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(18) who have participated in other clinical study within a month before the screening test or who intend to participate in the study period
(19) who are in a pregnancy or lactation period in the study period
(20) who are judged as unsuitable due to lifestyle questionnaire
(21) who regularly smoke
(22) who cannot carry out the test as instructed
(23) who are judged as unsuitable for the study by investigator for other reasons
Target sample size 54

Research contact person
Name of lead principal investigator
1st name Yukihiro
Middle name
Last name Takase
Organization DyDo DRINCO, INC.
Division name Healthcare Business Department
Zip code 530-0005
Address 2-7, Nakanoshima 2-chome, Kita-ku, Osaka, Japan
TEL 06-6222-2600
Email takase@dydo.co.jp

Public contact
Name of contact person
1st name Mariko
Middle name
Last name Kondo
Organization EP Mediate Co., Ltd.
Division name TTC center Clinical Research Planning Department
Zip code 162-0822
Address Tsuruya Bldg., 2-23, Shimomiyabi-cho, Shinjuku-ku, Tokyo
TEL 03-5657-4983
Homepage URL
Email kondo793@eps.co.jp

Sponsor
Institute EP Mediate Co., Ltd.
Institute
Department

Funding Source
Organization DyDo DRINCO, INC.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Medical Station Clinic Research Ethics Committee
Address 3-12-8, Takaban, Meguroku, Tokyo
Tel 03-6452-2712
Email t.saito@ttc-smo.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

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 20 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 54
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 No longer recruiting
Date of protocol fixation
2020 Year 12 Month 24 Day
Date of IRB
2020 Year 12 Month 24 Day
Anticipated trial start date
2021 Year 01 Month 21 Day
Last follow-up date
2021 Year 06 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 01 Month 19 Day
Last modified on
2021 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049151

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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