UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031939 |
|---|---|
| Receipt number | R000036448 |
| Scientific Title | The clinical trial of CoQ10 for saliva secresion or periodontal disease. |
| Date of disclosure of the study information | 2018/04/25 |
| Last modified on | 2019/07/29 17:51:25 |
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Basic information
Public title
The clinical trial of CoQ10 for saliva secresion or periodontal disease.
Acronym
The effect of CoQ10 on saliva secresion.
Scientific Title
The clinical trial of CoQ10 for saliva secresion or periodontal disease.
Scientific Title:Acronym
The effect of CoQ10 on saliva secresion.
Region
| Japan |
Condition
Condition
Dry mouth
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of CoQ10 on periodentol disease mainly of saliva secresion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
saliva secretion, oxidative stress of blood or saliva, saliva CoQ10 determination, Inspection of periodontal tissues.
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
6
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Dry mouth patients, placebo, 1month
Interventions/Control_2
Healthy volunteer. placebo, 1month
Interventions/Control_3
Dry mouth patients, ubiquinol, 100mg/day, 1month
Interventions/Control_4
Healthy volunteer, ubiquinol, 100mg/day, 1month
Interventions/Control_5
Dry mouth patients, ubiquinone, 100mg/day, 1month
Interventions/Control_6
Healthy volunteer, ubiquinone, 100mg/day, 1month
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects underwent an evaluation of salivary secresion using the Saxon's test were divied into a dry mouth group (salivary secretion<2g/2min) and a healthy subjects group (salivary secretion 2>g/2min).
Key exclusion criteria
Patients who had a medical history of significant cardiovascular disease, significant pulmonary obstructive disease, gastrointestinal obstructive disease, epilepsy, or Parkinson's disease.
Patients currently using drugs known to be xerostomic, taking disease-modifying anti-rheumatic drugs or predonisolone, undergoing radiotherapy for treatment of head and neck cancer.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koufuchi |
| Middle name | |
| Last name | Ryo |
Organization
Departments of Geriatric Dentistry
Division name
Tsurumi University School of Dental Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Japan
TEL
045-572-2888
saito-i@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Saito |
Organization
Tsurumi University School of Dental Medicine
Division name
Department of Pathology
Zip code
230-8501
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Japan
TEL
045-572-2888
Homepage URL
saito-i@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports Sicence, and Technology of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committees of Tsurumi University
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, Japan
Tel
045-581-1001
rinrishinsa@tsurumi-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 25 | 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
0
Results
.
Results date posted
| 2019 | Year | 07 | Month | 29 | Day |
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
| 2005 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2008 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 07 | Month | 15 | Day |
Date analysis concluded
| 2009 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 28 | Day |
Last modified on
| 2019 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036448
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
