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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046201
Receipt No. R000052726
Scientific Title Effects of consumption of the test food on the halitosis in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Date of disclosure of the study information 2021/11/26
Last modified on 2021/11/26

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Basic information
Public title Effects of consumption of the test food on the halitosis in healthy Japanese subjects
Acronym Effects of consumption of the test food on the halitosis in healthy Japanese subjects
Scientific Title Effects of consumption of the test food on the halitosis in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym Effects of consumption of the test food on the halitosis 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 consumption of the test food on halitosis and psychological distress due to halitosis in healthy Japanese subjects
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. The total score of questionnaire for halitosis at eight weeks after consumption (8w)
Key secondary outcomes 1. The amount of change of the total score of questionnaire for halitosis between screening (before consumption; Scr) and 8w

2. The measured values and amount of change from Scr in each of the following items at 8w: the total scores of each domain of questionnaire for halitosis, the each question items of visual analog scale, the each score of Profile of Mood States 2nd Edition (POMS2) Japanese version {Total Mood Disturbance (TMD), Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), and Friendliness (F)}, volatile sulfur compounds in the oral cavity, tongue coating score, oral moisture values, and the volume of saliva at rest

3. The measured values of each question items of POMS2 at 8w

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: Eight weeks
Test food: Tablet containing champignon extract
Administration: Take three tablets per day at any time during the day

* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2 Duration: Eight weeks
Test food: Placebo tablet
Administration: Take three tablets per day at any time during the day

* Daily dose should be taken within the day. If you forget to take the test food, 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. Japanese

2. Male or female

3. Subjects aged 20 or more

4. Healthy subjects

5. Subjects who are anxious about halitosis

6. Subjects who are judged as eligible to participate in the study by the physician

7. Subjects whose total score of questionnaire for halitosis is between 14 and 21 at Scr
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use

5. Subjects who regularly use antimicrobial drugs

6. Subjects currently taking medicines (include herbal medicines) and supplements

7. Subjects who are allergic to medications and/or the test-food-related products

8. Subjects who regularly use mouthwashes

9. Subjects who use artificial tooth, post crowns, dentures, implants, and bridges

10. Subjects who have receiving dental maintenance care at dental clinic, such as removing dental plaques and dental tartars within the last three months

11. Subjects who have a medical history, current illness, or are suspected to be a Sjogren's syndrome

12. Subjects who suffer from disorders associated with salivary gland such as dry mouse and salivary stone disease

13. Subjects who are being treated periodontosis or dental caries

14. Subjects whose salivary secretion volume at rest is less than 1.0 g/10 min

15. Subjects who are smokers

16. Subjects who are pregnant, breast-feeding, and planning to become pregnant

17. Subjects who suffer from COVID-19

18. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

19. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Takara
Organization Medical Corporation Seishinkai, Takara Clinic
Division name Director
Zip code 141-0022
Address 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL 03-5793-3623
Email t-takara@takara-clinic.com

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 Greenhouse Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Medical Corporation Yuseikai, Horiuchi Dental 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 IRB@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)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

医療法人社団優正会 堀内歯科医院 (東京都)
Medical Corporation Yuseikai, Horiuchi Dental Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 26 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 Open public recruiting
Date of protocol fixation
2021 Year 11 Month 17 Day
Date of IRB
2021 Year 11 Month 17 Day
Anticipated trial start date
2021 Year 11 Month 24 Day
Last follow-up date
2022 Year 06 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 26 Day
Last modified on
2021 Year 11 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052726

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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