UMIN-CTR Clinical Trial

Basic information
Public title	A clinical trial for 8 continuous weeks intake of HK1502 that are solid preparations blended with vitamin.
Acronym	A clinical trial for 8 continuous weeks intake of HK1502.
Scientific Title	A clinical trial for 8 continuous weeks intake of HK1502 that are solid preparations blended with vitamin.
Scientific Title:Acronym	A clinical trial for 8 continuous weeks intake of HK1502.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of HK1502 that are solid preparations blended with vitamin on 8 continuous weeks intake in japanese healthy adult male and female.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	*Skin AGE fluorometry *Doctor's findings such as subjective or objective symptoms and medical observations after the clinical trial start
Key secondary outcomes	*Questionnaire survey(five-point scale) *Physical examinations such as height, body weight, blood pressure and others *Subject diary(doctor's findings such as expression presence or absence of adverse events)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Each subjects consumed HK1502 that are solid preparations blended with vitamin for 8 continuous weeks.
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	35 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Subjects(japanese male and female) who are able to show their willingness of participating to the clinical trial, and who are able to obtain written consent to participate in the clinical trial after understanding explanation of the clinical trial. 2)Subjects who aged 35 years-old to 65 years-old. 3)BMI 18.5 more. 4)Subjects who are not regularly consuming supplements that are some possibility of having a negative influence on the clinical trial, or who are able to stop the supplements from two weeks before the clinical trial start to the end of the clinical trial. 5)The right hand is dominant hand.
Key exclusion criteria	1)Subjects who suffer any disease at present and who are going to take continuous medical treatments during the clinical trial, or who are going to use the over-the-counter drug. 2)Subjects who have trauma on the middle fingertip of the left hand, and who have a negative influence on the skin AGE fluorometry. 3)Subjects who have hypersensitivity or allergic reaction to a certain drug medicine or food. 4)Subjects who have an operation career such as hepatectomy, gastrectomy, gastrointestinal suturesin, intestinal resection, transplanting and others in a digestive organ. 5)Subjects who have impaired respiratory and cardiovascular organ. 6)Subjects with experience of alcoholism, or who drink liquor excessively(pure alcohol conversion : over-60g per day). 7)Subjects who have participated in other clinical trials and use tests that apply foods and others within the last 12 weeks prior to the current clinical trial. 8)Subjects who apply to the following. (1)Male subjects who donated 400ml of blood within the last 12 weeks prior to the current clinical trial. In female, within the last 16 weeks. (2)Subjects who donated 200ml of blood within the last 4 weeks prior to the current clinical trial. (3)Subjects who donated components of blood such as blood platelet and blood plasma within the last 2 weeks prior to the current clinical trial. (4)Subjects who have had experiences of a blood collecting conforming to the above matters. 9)Subjects who are the pregnant or breast-feeding woman. 10)Subjects who are planning to become the pregnant woman during the clinical trial. 11)Others who have been determined ineligible or undesirable by investigator.
Target sample size	23

Research contact person
Name of lead principal investigator	1st name Tomohiko Middle name Last name Yamaguchi
Organization	DAIICHI SANKYO HEALTHCARE CO., LTD.
Division name	R&D Department
Zip code	103-8234
Address	3-14-10 Nihonbashi Chuo-ku, Tokyo 103-8234, JAPAN
TEL	03-5255-6330
Email	yamaguchi.tomohiko.m6@daiichisankyo-hc.co.jp

Public contact
Name of contact person	1st name Yukiyoshi Middle name Last name Katsumata
Organization	Derma Labo, inc.
Division name	headquarter
Zip code	060-0001
Address	2 Kita 1-jo, Nishi 5-chome, Chuo-ku, Sapporo, Hokkaido 060-0001, JAPAN
TEL	011-205-0781
Homepage URL
Email	Y.Katsumata@dermalabo.co.jp

Sponsor
Institute	Kojinkai, Association of Medical Corporation Hosui General Medical Clinic.
Institute
Department

Funding Source
Organization	DAIICHI SANKYO HEALTHCARE CO., LTD. R&D Department
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Health Sciences Research Institute, Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Hosui General Medical Clinic
Address	1-4, Nishi 2-chome, Minami 7-jo, Chuou-ku,Sappro 064-0807, Japan
Tel	011-530-0011
Email	h.fujita@dermalabo.co.jp

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	デルマラボ株式会社（北海道）Derma Labo, inc.(Hokkaido prif.)

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 01 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	23
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	2018 Year 07 Month 12 Day
Date of IRB	2018 Year 07 Month 26 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2018 Year 11 Month 16 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 07 Month 13 Day
Last modified on	2019 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038003

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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