Unique ID issued by UMIN | UMIN000030260 |
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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 |
Study on blood kinetics of processed plant powder
Study on blood kinetics of processed plant powder
Study on blood kinetics of processed plant powder
Study on blood kinetics of processed plant powder
Japan |
Healthy adult
Adult |
Others
NO
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.
Efficacy
Amount of saponin in plasma
Blood test (hematologic, biochemical tests)
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Dose comparison
2
Prevention
Food |
On the day intake of the test food-1
Wash out
On the day intake of the test food-2
On the day intake of the test food-2
Wash out
On the day intake of the test food-1
40 | years-old | <= |
60 | years-old | > |
Male and Female
1)Age: 40 and over, below 60.
2)Sex: healthy Japanese males and females who do not suffer from any illness.
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.
12
1st name | |
Middle name | |
Last name | Toya Hidemasa |
HUMA R&D CORP
Clinical Development Division
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
81-3-3431-1260
toya@huma-c.co.jp
1st name | |
Middle name | |
Last name | Ochitani Daisuke |
HUMA R&D CORP
Clinical Development Division
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
81-3-3431-1260
ochitani@huma-c.co.jp
HUMA R&D CORP
Kobayashi Pharmaceutical Co., Ltd.
Profit organization
NO
2017 | Year | 12 | Month | 05 | Day |
Unpublished
Completed
2017 | Year | 11 | Month | 10 | Day |
2017 | Year | 12 | Month | 05 | Day |
2017 | Year | 12 | Month | 04 | Day |
2018 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034556
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