UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049528 |
|---|---|
| Receipt number | R000056396 |
| Scientific Title | Study to evaluate the effect of plant extract on oral bacteria (dose verification) |
| Date of disclosure of the study information | 2022/11/29 |
| Last modified on | 2023/05/19 10:03:48 |
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Basic information
Public title
Test to evaluate the effect of plant extract on oral bacteria (dose verification)
Acronym
Test to evaluate the effect of plant extract on oral bacteria (dose verification)
Scientific Title
Study to evaluate the effect of plant extract on oral bacteria (dose verification)
Scientific Title:Acronym
Study to evaluate the effect of plant extract on oral bacteria (dose verification)
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the dose of reducing effect on oral bacteria by intake the extract.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral Bacteriology
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 1 day
Test food: Extract (low dose : 9 mg)
Dosage: Take after the first saliva collection. 1 tablet, once a day.
Interventions/Control_2
Duration: 1 day
Test food: Placebo
Dosage: Take after the first saliva collection. 1 tablet, once a day.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Age:Men and women between 20 and 60 years old (at the time of obtaining consent)
2 Admission/Foreign:Foreign
3 Healthy subjects (healthy subjects in this study are those who do not have any serious organ disorders or specific diseases, and who are not receiving any related treatment or any drug therapy. Whether or not a person qualifies as an able-bodied person is based on the person's declaration at the start of the examination).
4 Those who have 20 or more teeth as far as self-reporting is concerned.
5 Those who do not have oral diseases with treatment.
6 Those who is conscious of oral health
7 Persons who have given written consent to participate in the research
Key exclusion criteria
1 Those taking medications that may affect the test results.
2 Persons with a history of hypersensitivity to grape dextrins
3 Persons who have a smoking habit
4 Those who have used antibiotics and antimicrobials within the past month.
5 Those who cannot abstain
5 from alcohol from the day before the examination.
6 Persons with diseases that may affect test results [epilepsy, diabetes, etc.], persons with systemic condition problems
7 Those who cannot eat or drink from the time they wake up until around 3:00 p.m. and cannot restrict oral care (gargling, brushing teeth, mouthwash, etc.) (only water can be consumed for a certain period of time).
8 Persons using Listerine or other antibacterial oral rinses during and prior to the study period
9 Those who regularly visit the dentist for oral care.
10 Those with dry mouth and low saliva production
11 Persons who habitually consume grape products (grapes, raisins, wine, 100% grape juice, etc.)
12 Persons using health foods, supplements, and medications that would affect this study
13 Pregnant or intending to become pregnant during the study period, or breastfeeding
14 Participation in another clinical trial within 3 months prior to obtaining consent or current participation in another clinical trial.
15 Persons for whom, in the judgment of the principal investigator or subinvestigator, the conduct of the study may increase the risk to the subject or may not provide sufficient data.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Aida |
Organization
NIPPN CORPORATION
Division name
Innovation Center, Central Research Laboratory
Zip code
243-0041
Address
5-1-3 Midorigaoka, Atsugi City, Kanagawa Prefecture
TEL
042-222-6963
kaida@nippn.co.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ohno |
Organization
Clinical Creative Co., Ltd.
Division name
Pharmaceutical Development Division
Zip code
062-0933
Address
1-12-102, Hiragishi 3-13-1-12, Toyohira-ku, Sapporo City, Hokkaido
TEL
09031166218
Homepage URL
k-ohno@cli-creative.com
Sponsor or person
Institute
Clinical Creative Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NIPPN CORPORATION
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Trial Review Committee, Kitahiroshima Hospital, Jounin-kai Social Medical Corporation
Address
6-2-2 Chuo, Kitahiroshima City, Hokkaido
Tel
011-373-5811
m-nakahara@cli-creative.com
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
| 2022 | Year | 11 | Month | 29 | 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
| 2022 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 16 | Day |
Last modified on
| 2023 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056396
