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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030260
Receipt No. R000034556
Scientific Title Study on blood kinetics of processed plant powder
Date of disclosure of the study information 2017/12/05
Last modified on 2018/03/01

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Basic information
Public title Study on blood kinetics of processed plant powder
Acronym Study on blood kinetics of processed plant powder
Scientific Title Study on blood kinetics of processed plant powder
Scientific Title:Acronym Study on blood kinetics of processed plant powder
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the effect of plant-powder containing tablets on kinetics of blood components, healthy Japanese males and females aged 40 and over, below 60, who do not suffer from any illness, will be selected, and two types of pre-processed/processed plant-powder containing tablets will be administered once.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of saponin in plasma
Key secondary outcomes Blood test (hematologic, biochemical tests)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 On the day intake of the test food-1
Wash out
On the day intake of the test food-2
Interventions/Control_2 On the day intake of the test food-2
Wash out
On the day intake of the test food-1
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
40 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria 1)Age: 40 and over, below 60.
2)Sex: healthy Japanese males and females who do not suffer from any illness.
Key exclusion criteria 1)Currently in treatment with medication or seeing a doctor for treatment.
2)Previous history of hepatic disorder, severe kidney, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disorder, or a complication of these.
3)Pregnant, having the potential to become pregnant, or having anemia.
4)Previous history of drug allergy, food allergy, or any abnormality resulted from ingestion of the study plant.
5)Intake of a prescription drug, an over-the-counter drug, a quasi drug, a food product, a health food product, etc. that contains the study plant or a relative plant within the last month.
6)Extreme faddiness.
7)Extremely irregular lifestyle including irregular meal and sleeping patterns.
8)Presence or previous history of mental disorder (depression, etc.).
9)Participation in any other clinical study involving human subjects within 3 months or current participation in any other clinical study involving human subjects.
10)Regular alcohol consumption with an average of 30g/day or more (500 ml of beer, 180 ml of sake), or alcohol consumption of 30g/day or more (500 ml of beer, 180 ml of sake) for at least four days/week.
11)Smoker.
12)Subjects who are deemed to be unsuitable by the investigator.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toya Hidemasa
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Email toya@huma-c.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Homepage URL
Email ochitani@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Kobayashi 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 12 Month 05 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 11 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 05 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 12 Month 04 Day
Last modified on
2018 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034556

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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