Unique ID issued by UMIN | UMIN000046201 |
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Receipt number | 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 | 2023/02/06 15:36:09 |
Effects of consumption of the test food on the halitosis in healthy Japanese subjects
Effects of consumption of the test food on the halitosis in healthy Japanese subjects
Effects of consumption of the test food on the halitosis in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on the halitosis in healthy Japanese subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on halitosis and psychological distress due to halitosis in healthy Japanese subjects
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. The total score of questionnaire for halitosis at eight weeks after consumption (8w)
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
2
Treatment
Food |
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.
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.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
60
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Greenhouse Co., Ltd
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Medical Corporation Yuseikai, Horiuchi Dental Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
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)
2021 | Year | 11 | Month | 26 | Day |
Unpublished
66
Completed
2021 | Year | 11 | Month | 17 | Day |
2021 | Year | 11 | Month | 17 | Day |
2021 | Year | 11 | Month | 24 | Day |
2022 | Year | 06 | Month | 05 | Day |
2021 | Year | 11 | Month | 26 | Day |
2023 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052726
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