UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033381 |
|---|---|
| Receipt number | R000038003 |
| Scientific Title | A clinical trial for 8 continuous weeks intake of HK1502 that are solid preparations blended with vitamin. |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2019/09/10 14:02:20 |
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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
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
Y.Katsumata@dermalabo.co.jp
Sponsor or person
Institute
Kojinkai, Association of Medical Corporation
Hosui General Medical Clinic.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038003
