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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023843
Receipt No. R000027473
Scientific Title Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) on QOL improvement in the elderly
Date of disclosure of the study information 2016/08/31
Last modified on 2019/09/02

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Basic information
Public title Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) on QOL improvement in the elderly
Acronym Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) on QOL improvement in the elderly
Scientific Title Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) on QOL improvement in the elderly
Scientific Title:Acronym Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) on QOL improvement in the elderly
Region
Japan

Condition
Condition none
Classification by specialty
Surgery in general Blood transfusion Not applicable
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the efficacy of Reduced form of Coenzyme Q10 to several biological parameters relates to QOL in the elderly
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SF-36
digit symbol test
These items will be determined at 0, 6 and 12 months.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Reduced form of Coenzyme Q10 (100mg/day), 12 months,
Interventions/Control_2
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subject are healthy person over 60 years old.
Key exclusion criteria 1.Under medication.
2.Entry another clinical study which ongoing or performed within 3 month.
3.Doctor did not allow to entry to this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name toshiki
Middle name
Last name mano
Organization Tama University institute for healthcare
Division name Tama University institute for healthcare
Zip code 108-0071
Address Ramiaru Shiroganedai 503, 3-15-11, Shiroganedai, Minato-ku, Tokyo, Japan
TEL 03-5422-9995
Email mano@tama.ac.jp

Public contact
Name of contact person
1st name Yo
Middle name
Last name Miyakoshi
Organization KANEKA CORPORATION
Division name QOL Division
Zip code 107-6028
Address 1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL 050-3133-9895
Homepage URL
Email Yo.miyakoshi@kaneka.co.jp

Sponsor
Institute Tama University
Institute
Department

Funding Source
Organization KANEKA CORPORATION
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 suda clinic
Address 2-8-14,takadanobaba,sinnjyuku-ku,tokyo,Japan
Tel 03-3207-8161
Email yo.miyakoshi@kaneka.co.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
2016 Year 08 Month 31 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
2015 Year 11 Month 09 Day
Date of IRB
2015 Year 11 Month 30 Day
Anticipated trial start date
2015 Year 11 Month 09 Day
Last follow-up date
2019 Year 09 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 30 Day
Last modified on
2019 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027473

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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