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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023459
Receipt No. 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

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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
Institute KSO Corporation
Institute
Department

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
URL(English) https://upload.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


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