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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041108
Receipt No. R000046947
Scientific Title Validation study on the effects on liver function and skin barrier function by intake of adlay
Date of disclosure of the study information 2020/07/15
Last modified on 2020/07/15

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Basic information
Public title Validation study on the effects on liver function and skin barrier function by intake of adlay
Acronym Validation study on the effects on liver function and skin barrier function by intake of adlay
Scientific Title Validation study on the effects on liver function and skin barrier function by intake of adlay
Scientific Title:Acronym Validation study on the effects on liver function and skin barrier function by intake of adlay
Region
Japan

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

Objectives
Narrative objectives1 Evaluate the effects of liver function and skin barrier function by adlay tea intake for 8 weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -liver function (AST, ALT, gamma-GTP )
-skin hydration (Transepidermal water loss, Moisture)
At the beginning of the test or after the intake for 8 weeks.
Key secondary outcomes -Blood test (total protein, albumin, ,blood neutral fat (TG), total cholesterol, HDL-cholesterol, LDL-cholesterol, urea nitrogen , ALP, CPK, total bilirubin, uric acid, urea nitrogen, creatinine, sodium, potassium, chlorine, calcium, phosphorus, magnesium, LDH, white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, MCV, MCH, MCHC)
-Physical examination (body height, weight, BMI, blood pressure, pulse)
-Food questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake 500mL of adlay tea daily for 8 weeks.
Interventions/Control_2 Intake 500ml of barley tea daily for 8 weeks.
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
65 years-old >
Gender Female
Key inclusion criteria 1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Japanese women who are 20 years old or more and under 65 years old
3.Persons who are the bottom 70 of the value of skin hydration at screening
Key exclusion criteria 1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food
3.Persons who usually take a large amount of test food
4.Persons whose ALT or AST is over 51 U/L at screening
5.Persons whose gamma-GTP is over 101 U/L at screening
6.Persons whose habitually consume higher amount of alcohol (>60g alcohol/day)
7.Persons who have skin disease such as atopic dermatitis, urticaria, eczema and dermatitis.
8.Persons who regularly use medicines, specified insurance foods, health foods, etc. that may affect liver function and skin function
9.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
10.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
11.Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Hirohito
Middle name
Last name Ishikawa
Organization Healthcare Systems Co., Ltd.
Division name Research and Development Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Email ishikawa@hc-sys.jp

Public contact
Name of contact person
1st name Hitomi
Middle name
Last name Izumi
Organization Healthcare Systems Co., Ltd.
Division name Research and Development Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Homepage URL
Email izumi@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization Cabinet Office
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor Oyama city
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of Healthcare Systems Co., Ltd.
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel 03-6809-2722
Email soumu@hc-sys.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

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 15 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
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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 18 Day
Date of IRB
2020 Year 06 Month 18 Day
Anticipated trial start date
2020 Year 08 Month 08 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 15 Day
Last modified on
2020 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046947

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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