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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025163
Receipt No. R000028945
Scientific Title Clinical efficiency of transoral administration of GliSODin against aging-related dysfunction in motor organ.
Date of disclosure of the study information 2016/12/09
Last modified on 2020/09/08

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Basic information
Public title Clinical efficiency of transoral administration of GliSODin against aging-related dysfunction in motor organ.
Acronym Efficiency of GliSODin
Scientific Title Clinical efficiency of transoral administration of GliSODin against aging-related dysfunction in motor organ.
Scientific Title:Acronym Efficiency of GliSODin
Region
Japan

Condition
Condition Locomotive Syndrome
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate the preventive effects of transoral intake of GliSODin against age-related dysfunction in motor organ
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes motor function
Key secondary outcomes oxidative stress level
antioxidative capacity

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 GliSODin
Interventions/Control_2 Placebo
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria Volunteer with low back or knee pain and gait instability caused by motor weakness
Key exclusion criteria Volunteer with diseases including internal midicine, psychogenic disorders, neuromuscular diseases, postoperative state of orthopaedic surgery, allergy against melon and wheat.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Koike
Organization Juntendo Tokyo Koto Geriatric Medical Center
Division name Department of Orthopaedic Surgery
Zip code 136-0075
Address 3-3-20 Shinsuna, Koto-ku, Tokyo
TEL 03-5632-3111
Email ortho-m.koike@juntendo.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Koike
Organization Juntendo Tokyo Koto Geriatric Medical Center
Division name Department of Orthopaedic Surgery
Zip code 136-0075
Address 3-3-20 Shinsuna, Koto-ku, Tokyo
TEL 03-5632-3111
Homepage URL https://jrct.niph.go.jp/en-latest-detail/jRCTs031180310
Email ortho-m.koike@juntendo.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Juntendo Tokyo Koto Geriatric Medical Center
Institute
Department

Funding Source
Organization Nutrition Act Co., Ltd.
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 Juntendo Clinical Research Review Board(CRB3180012)
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel 03-5802-1584
Email crbjun@juntendo.ac.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 順天堂東京江東高齢者医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 09 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
2016 Year 12 Month 08 Day
Date of IRB
2016 Year 10 Month 18 Day
Anticipated trial start date
2016 Year 12 Month 09 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 06 Month 09 Day
Date trial data considered complete
2020 Year 06 Month 09 Day
Date analysis concluded
2020 Year 06 Month 09 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 06 Day
Last modified on
2020 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028945

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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