UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019107 |
|---|---|
| Receipt number | R000022067 |
| Scientific Title | A exploratory study for the effects of antioxidant form of coenzyme Q10 (ubiquinol) |
| Date of disclosure of the study information | 2015/09/24 |
| Last modified on | 2019/01/19 19:13:29 |
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Basic information
Public title
A exploratory study for the effects of antioxidant form of coenzyme Q10 (ubiquinol)
Acronym
A exploratory study for the effects of antioxidant form of coenzyme Q10(ubiquinol)
Scientific Title
A exploratory study for the effects of antioxidant form of coenzyme Q10 (ubiquinol)
Scientific Title:Acronym
A exploratory study for the effects of antioxidant form of coenzyme Q10(ubiquinol)
Region
| Japan |
Condition
Condition
Subjects with tendency of constipation or diarrhea
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of antioxidant form of coenzyme Q10 for intestinal environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)The change of defecation and fecal form
2)QOL
3)Cognitive function
These are evaluate in baseline, 12 weeks, and 24 weeks after intervention
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
antioxidant form of coenzyme Q10 (Ubiquinol) 50mg
3 capsuls (150mg) 1 time a day
A group for 24 weeks, B group for 12 weeks
Interventions/Control_2
placebo capsule
3 capsuls1 time a day
B group 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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subject are over 60 years old with tendency of constipation or diarrhea
Key exclusion criteria
1) Patients who have allergic to test food
1) Patients who have serious complications
2) Pregnant
3) Others
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sho Suzuki |
Organization
Yuri-Kumiai General Hospital
Division name
Department of Gastroenterology
Zip code
Address
38, Kawaguchiazayago, Yurihonjoshi, Akita, Japan
TEL
0184-27-1200
s.sho.salubriter.mail@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho Suzuki |
Organization
Yuri-Kumiai General Hospital
Division name
Department of Gastroenterology
Zip code
Address
38, Kawaguchiazayago, Yurihonjoshi, Akita, Japan
TEL
0184-27-1200
Homepage URL
s.sho.salubriter.mail@gmail.com
Sponsor or person
Institute
Yuri-Kumiai General Hospital
Institute
Department
Personal name
Funding Source
Organization
KANEKA Coporation
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 24 | Day |
Last modified on
| 2019 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022067
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
