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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027495
Receipt No. R000031509
Scientific Title Evaluation for efficacy of liver function by ingestion of supplement containing plant derived extractive
Date of disclosure of the study information 2017/05/26
Last modified on 2018/06/15

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Basic information
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
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization Shiratori Pharmaceutical Co., Ltd.
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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 26 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
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
Other related information

Management information
Registered date
2017 Year 05 Month 25 Day
Last modified on
2018 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031509

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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