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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038554
Receipt No. R000043906
Scientific Title The effects of the test food on the mouth dryness in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Date of disclosure of the study information 2019/11/12
Last modified on 2020/03/25

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Basic information
Public title A verification study of the improvement effects of the test food on mouth dryness
Acronym A verification study of the improvement effects of the test food on mouth dryness
Scientific Title The effects of the test food on the mouth dryness in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym The effects of the test food on the mouth dryness in healthy Japanese subjects
Region
Japan

Condition
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects of the test food on the mouth dryness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The amount of changes of visual analogue scale (VAS) values of subjective mouth dryness between at screening (before test-food consumption; Scr) and 8 weeks after the start of test-food consumption (8w)
Key secondary outcomes 1. The amount of changes of VAS values in the subjective symptom of mouth dryness between at Scr and 4 weeks after the start of test-food consumption (4w)

2. The amount of changes in the following items between at Scr and 4w, and 8w
VAS values of subjective symptoms of longing for drinking, difficulty eating and oral consistency; the volume of saliva; salivary amylase concentration; oral moisture values; and volatile sulfur compounds in the oral cavity

3. The logarithmic transformation values or the amount of changes in the following items between at Scr and 4w, and 8w
Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola

4. The ratio of subjects whose measured VAS values of subjective mouth dryness at 8w decreasing by 50% or more compared to Scr.

5. The ratio of subjects whose measured VAS values of subjective mouth dryness at 8w decreasing by 25% or more compared to Scr.

6. The ratio of subjects whose oral moisture level 8w decreasing compared to Scr.

7. The ratio of subjects whose oral moisture values at 8w is 28.0 or more.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 8 weeks
Test food: Test food
Administration: Take 1 tablet, three times a day.

* If you forget to take the tablet, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 8 weeks
Test food: Placebo
Administration: Take 1 tablet, three times a day.

* If you forget to take the tablet, take it as soon as you remember within the 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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese adult subjects
2. Subjects who feel thirsty in the mouth
3. Subjects who are judged as ineligible to participate in the study by the physician
4. Subjects whose saliva test (Saxon test) is 2 g or more in 2 minutes
5. Subjects whose oral moisture level [using Mucus (R)] is relatively low
6. Subjects whose VAS values of subjective mouth dryness is relatively high
Key exclusion criteria Subjects who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. are undergoing medical treatment or have a medical history of a salivary gland disorder (including sialadenitis, sialolithiasis, Sjogren's syndrome, and salivary gland tumors), or Subjects who removed a salivary gland
4. are undergoing medical treatment of autoimmune disease
5. are currently undergoing treatment for the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and/or any other chronic diseases
6. use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
7. are currently taking medicines (include herbal medicines) and supplements
8. buy more than 2 packs of 9 chewing gum sheets or 14 to 20 chewing gum a month, or eat about 40 chewing gum a month
9. are smokers
10. use implants, tooth caps, dentures, and bridges
11. have received treatment of periodontosis or with antimicrobial drugs (including antibacterial drugs) within the last three months
12. have receiving dental maintenance care, such as removing dental plaques and dental tartars within the last three months
13. are under treatment or diagnosed with any of dental diseases
14. regularly use floss, interdental cleaner, and mouthwash
15. are allergic to medicines and/or the test food related products
16. are pregnant, lactation, or planning to become pregnant
17. have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
18. are judged as ineligible to participate in the study by the physician
Target sample size 52

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization Toyo Sugar Refining Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email info@takara-clinic.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 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 12 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 56
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
2019 Year 10 Month 25 Day
Date of IRB
2019 Year 10 Month 25 Day
Anticipated trial start date
2019 Year 11 Month 12 Day
Last follow-up date
2020 Year 02 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 12 Day
Last modified on
2020 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043906

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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