UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023843 |
|---|---|
| Receipt number | 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 09:23:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Yo.miyakoshi@kaneka.co.jp
Sponsor or person
Institute
Tama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027473
