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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031939
Receipt No. 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

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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
Email 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
Email saito-i@tsurumi-u.ac.jp

Sponsor
Institute Tsurumi University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036448

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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