UMIN-CTR Clinical Trial

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

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Basic information

Public title

A verification study of improving on the oral cavity environment of the test food: an open-label trial

Acronym

A verification study of improving on the oral cavity environment of the test food

Scientific Title

A verification study of improving on the oral cavity environment of the test food: an open-label trial

Scientific Title:Acronym

A verification study of improving on the oral cavity environment of the test food

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 for 4 weeks on the oral cavity environment in healthy Japanese subjects.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

A. actinomycetemcomitans, P. gingivalis, P. intermedia, T. forsythensis, T. denticola, F. nucleatum

* Measure the values at screening (before consumption) and 4 weeks after consumption.

Key secondary outcomes

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.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

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.

Interventions/Control_2


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 who have no tooth decay.

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

Key exclusion criteria

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.

Target sample size

27


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 or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



Funding Source

Organization

Autobahn 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

2018 Year 12 Month 28 Day


Related information

URL releasing protocol

Unpublished

Publication of results

Published


Result

URL related to results and publications

http://www.pieronline.jp/content/article/0386-3603/47080/1297

Number of participants that the trial has enrolled

27

Results

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.

Results date posted

2021 Year 05 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 08 Month 30 Day

Baseline Characteristics

Refer to the paper

Participant flow

Refer to the paper

Adverse events

Refer to the paper

Outcome measures

Refer to the paper

Plan to share IPD

Undecided

IPD sharing Plan description

To require consultation among related companies


Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 12 Month 18 Day

Date of IRB

2018 Year 12 Month 18 Day

Anticipated trial start date

2018 Year 12 Month 29 Day

Last follow-up date

2019 Year 03 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 12 Month 28 Day

Last modified on

2021 Year 05 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040329


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name