UMIN-CTR Clinical Trial

Public title

Evaluation for efficacy of liver function by ingestion of supplement containing plant derived extractive

Acronym

Evaluation for efficacy of liver function by ingestion of supplement containing plant derived extractive

Scientific Title

Evaluation for efficacy of liver function by ingestion of supplement containing plant derived extractive

Scientific Title:Acronym

Evaluation for efficacy of liver function by ingestion of supplement containing plant derived extractive

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to evaluate for the efficacy of the supplement containing plant derived extractive on subjects with high normal liver function.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Biomarkers of liver function (ALT and AST) before and 4, 8, 12 weeks after the intervention with the test food

Key secondary outcomes

Biomarkers of liver function (gamma-GT and ALP), POMS2, LPO, Physical, Hematologic, Blood biochemical, Urinalysis, and Psychological values before and 4, 8, 12 weeks after the intervention with the test food

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of supplement containing plant derived extractive for 12 consecutive weeks (4 capsules, 1 time a day)

Interventions/Control_2

Intake of placebo for 12 consecutive weeks (4 capsules, 1 time a day)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Healthy males and females aged 20-64 years old
2.Subjects with BMI greater than 22.0 and less than 30 kg/m^2
3.Subjects who ALT levels were top 40 out of the participants applying to the criteria (both ALT and AST less than 50 U/L)
4.Subjects who has normal or borderline liver function judged by clinical investigator

Key exclusion criteria

1.Subjects who constantly use health food richly containing involvement ingredient
2.Subjects who constantly use supplements or drug affecting the liver function
3.Subjects with chronic illness or medication
4.Subjects who has serious illness such as diabetes, liver disease, kidney disease, heart disease
5.Subjects who are in danger of allergy to the study
6.Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies
7.Subjects who are judged as unsuitable for the study from clinical measurements for preliminary tests and measurements
8.Subjects who are positive for HCV antibody or HbsAg
9.Subjects who intend to become pregnant or lactating
10.Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
11.Subjects who are judged as ineligible by clinical investigator

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Yasuhiro Sato

Organization

Shiratori Pharmaceutical Co., Ltd.

Division name

Research and Development Dept

Zip code

Address

2-3-7 Akanehama, Narashino-city, Chiba-pref

TEL

047-453-3161

Email

y-sato@shiratori-pharm.co.jp

Name of contact person

1st name
Middle name
Last name	Kotoha Isobe

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

k.isobe@ttc-tokyo.co.jp

Institute

TTC Co., Ltd.

Institute

Department

Personal name

Organization

Shiratori Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

05

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

05

Month

16

Day

Date of IRB

Anticipated trial start date

2017

Year

05

Month

27

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

05

Month

25

Day

Last modified on

2018

Year

06

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031509