Unique ID issued by UMIN | UMIN000035393 |
---|---|
Receipt number | R000040329 |
Scientific Title | A verification study of improving on the oral cavity environment of the test food: an open-label trial |
Date of disclosure of the study information | 2018/12/28 |
Last modified on | 2021/05/27 11:04:53 |
A verification study of improving on the oral cavity environment of the test food: an open-label trial
A verification study of improving on the oral cavity environment of the test food
A verification study of improving on the oral cavity environment of the test food: an open-label trial
A verification study of improving on the oral cavity environment of the test food
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food for 4 weeks on the oral cavity environment in healthy Japanese subjects.
Efficacy
Confirmatory
Pragmatic
Not applicable
A. actinomycetemcomitans, P. gingivalis, P. intermedia, T. forsythensis, T. denticola, F. nucleatum
* Measure the values at screening (before consumption) and 4 weeks after consumption.
1. Visual Analogue Scale (VAS) of subjective symptoms
Halitosis, swelling of gums, surface roughness of tooth, oral discomfort, dry mouth, and, stickiness in the mouth
2. The concentration of serum IGF-1
3. The concentration of salivary IGF-1
* Measure the values at screening (before consumption) and 4 weeks after consumption.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
Duration: 4 weeks
Test materials: HGH crystal
Dose: 1 pack, three times per day
Administration: Maintain the test food in the mouth for 40 seconds and swallow it before each meal.
* 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. Healthy Japanese adult subjects who have no tooth decay.
2. Subjects who are judged as eligible to participate in the study by the physician.
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction.
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD).
3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases.
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily.
5. Subjects who are currently taking medications (including herbal medicines) and dietary supplements.
6. Subjects who are identified at least severe tooth decay by dentist.
7. Subjects who use implants, tooth caps, dentures, and bridges.
8. Subjects who have received treatment of periodontosis or with antimicrobial drugs (including antibacterial drugs) within the last three months.
9. Subjects who have received dental maintenance care, such as removing dental plaques and dental tartars within the last three months.
10. Subjects who are under treatment or diagnosed with any of dental diseases.
11. Subjects who regularly use floss, interdental cleaner, and mouthwash.
12. Subjects who are allergic to medicines and/or the test food related products.
13. Subjects who are pregnant, breast-feeding, or planning to become pregnant.
14. Subjects who 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.
15. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician.
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1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
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.
Autobahn Co. Ltd.
Profit organization
Medical Corporation Seishinkai, Takara 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
info@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)
2018 | Year | 12 | Month | 28 | Day |
Unpublished
Published
http://www.pieronline.jp/content/article/0386-3603/47080/1297
27
Morinaga H, Tanaka M. HGH Crystal MD(R) Improves the Oral Environment-An Open-label,Observational Before-after Study-. Jpn Pharmacol Ther. 2019; 47(8): 1297-1313.
2021 | Year | 05 | Month | 27 | Day |
2019 | Year | 08 | Month | 30 | Day |
Refer to the paper
Refer to the paper
Refer to the paper
Refer to the paper
Undecided
To require consultation among related companies
Completed
2018 | Year | 12 | Month | 18 | Day |
2018 | Year | 12 | Month | 18 | Day |
2018 | Year | 12 | Month | 29 | Day |
2019 | Year | 03 | Month | 29 | Day |
2018 | Year | 12 | Month | 28 | Day |
2021 | Year | 05 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040329