UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030260
Receipt number 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 08:39:18

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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 or person

Institute

HUMA R&D CORP

Institute

Department

Personal name



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

Value
https://center6.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