UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027495 |
|---|---|
| Receipt number | 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 18:14:07 |
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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
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
k.isobe@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031509
