UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023459
Receipt number R000027030
Scientific Title Effect of continuous ingestion of trial supplement on liver function. - A randomized, placebo-controlled, double-blind, parallel-group clinical trial -
Date of disclosure of the study information 2016/12/01
Last modified on 2017/02/01 15:32:27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of continuous ingestion of trial supplement on liver function. - A randomized, placebo-controlled, double-blind, parallel-group clinical trial -

Acronym

A clinical trial to study the effect of trial supplement on liver function.

Scientific Title

Effect of continuous ingestion of trial supplement on liver function. - A randomized, placebo-controlled, double-blind, parallel-group clinical trial -

Scientific Title:Acronym

A clinical trial to study the effect of trial supplement on liver function.

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of the trial supplement on maker of liver function.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

AST : Aspartate Aminotransferase
ALT : Alanine Aminotransferase
Gamma-GT : Gamma-Glutamic Transpeptidase

Point:0w, 4w, 8w, 12w

Key secondary outcomes



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

Treatment

Type of intervention

Food

Interventions/Control_1

Test food contained silymarin and curcumin, 4 tablets once day for 12weeks.

Interventions/Control_2

Control food not contained silymarin and curcumin, 4 tablets once a day for 12weeks.

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

Male and Female

Key inclusion criteria

1) Subjects that any one or more of the AST, ALT or gamma-GTP corresponds to criterion of JAPAN SOCIETY OF NINGEN DOCK. However, gamma-GTP of women is half of the value of setting limits.
2)Subjects who giving written informed consent

Key exclusion criteria

1)Subjects who are judged as unsuitable for the study by the investigator for AST, ALT, gamma-GTP.
2)Subjects who take drug having an effect on improvement of liver function.
3)Subjects who consecutively take dietary supplement or food including silymarin or curcumin (more than three times a week for more than half year).
4)Subjects who consecutively take dietary supplement or food and can't stop those foods from one week before to the end of the study.
5)Subjects who have allergy to silymarin, (extract of Silybum marianum) or curcumin (extract of Curcuma longa).
6)Subjects who have or had severe disorders (for example, liver function, kidney function, heart function, diabetes etc.) or thyroid disease, adrenal disease and other metabolic diseases.
7)Subjects who have chronic disease and consecutively use drug.
8)Subjects who have excessive drinking habits (apply to the following conditions). More than 100g alcohol consumption per day. More than 80g less than 100g alcohol consumption per day and drinking frequency is five days a week or more. More than 60g less than 80g alcohol consumption per day and drinking frequency is each day.
9)Subjects whose ifestyle is extremely irregular (for exsample, night work, day and night reversed style)
10)Subjects suffer from addiction to the drug or alcohol.
11)Subjects who are planned to participate in other clinical study.
12)Female with pregnancies, lactating or planning to become pregnant during the study.
13)Subjects who are judged as unsuitable for the study by the investigator for other reason.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitaka Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code


Address

13-4 Kodenma-cho, Chuo-ku, Tokyo, Japan

TEL

03-5641-4133

Email

yiwama@well-sleep.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiji Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code


Address

1-9-7 Shibaura, Minato-ku, Tokyo, Japan

TEL

03-3452-7733

Homepage URL


Email

yoshikawa@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

医療法人財団健康睡眠会 日本橋循環器科クリニック(Nihonbashi Cardiology Clinic)


Other administrative information

Date of disclosure of the study information

2016 Year 12 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


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

2016 Year 07 Month 04 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 03 Day

Last modified on

2017 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027030


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name