UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021221 |
|---|---|
| Receipt number | R000024160 |
| Scientific Title | Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) to fatigue |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2020/09/02 08:27:14 |
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Basic information
Public title
Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) to fatigue
Acronym
Anti-fatigue effect of Reduced form of Coenzyme Q10
Scientific Title
Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) to fatigue
Scientific Title:Acronym
Anti-fatigue effect of Reduced form of Coenzyme Q10
Region
| Japan |
Condition
Condition
None
Classification by specialty
| 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 fatigue
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic nervous system,
Oxidation stress,
Antioxidant activity,
Cognitive function,
Condition of sleep,
VAS(fatigue),
These items will be determined at 0, 4, 8 and 12 weeks.
Key secondary outcomes
Physical active mass
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Reduced form of Coenzyme Q10 ( 100mg/day), 3months, 25 healthy person.
Interventions/Control_2
Reduced form of Coenzyme Q10(150mg/day), 3months, 25 healthy person.
Interventions/Control_3
Placebo, 3months, 25 healthy person
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.age:over 20 y.o
2.healthy person
Key exclusion criteria
1.Under medication.
2.Take coenzyme Q10 supplement.
3.Take medicine that might impact the outcome measures.
4.Patient of serious disease such as diabetes, live disease, renal disease, heart disease, mental disease, disease to become the motive of fatigue, cardiovascular, nerve, allergy, insomnia.
5.Pregnant and women who wish to pregnant in this study period.
6.alcholism
7.Doctor did not allow to entry to this study.
8.Entry another clinical study which ongoing or performed within 1 month.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyoshi Watanabe |
Organization
Osaka City University
Division name
Center for Health Science Innovation,
Zip code
Address
9F,Tower-C,Knowledge Capital,Grand Front Osaka,3-1,Ofuka-cho,Kita-ku,Osaka, Japan, Zip 530-0011
TEL
06-6485-0288
chsi-b@ado.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Fujii |
Organization
KANEKA CORPORATION
Division name
QOL Division
Zip code
Address
1-12-32, Akasaka, Minato-ku, Tokyo, Japan, Zip107-6025
TEL
03-5574-8112
Homepage URL
Kenji.Fujii@kaneka.co.jp
Sponsor or person
Institute
Center for Health Science Innovation, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
KANEKA CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
大阪市立大学健康科学イノベーションセンター
Center for Health Science Innovation, Osaka City University
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 01 | 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 | 12 | Month | 04 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 30 | 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 | 02 | Month | 26 | Day |
Last modified on
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024160
