Unique ID issued by UMIN | UMIN000023459 |
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Receipt number | R000027030 |
Scientific Title | Effect of continuous ingestion of trial supplement on liver function. - A randomized, placebo-controlled, double-blind, parallel-group clinical trial - |
Date of disclosure of the study information | 2016/12/01 |
Last modified on | 2017/02/01 15:32:27 |
Effect of continuous ingestion of trial supplement on liver function. - A randomized, placebo-controlled, double-blind, parallel-group clinical trial -
A clinical trial to study the effect of trial supplement on liver function.
Effect of continuous ingestion of trial supplement on liver function. - A randomized, placebo-controlled, double-blind, parallel-group clinical trial -
A clinical trial to study the effect of trial supplement on liver function.
Japan |
Healthy volunteer
Adult |
Others
NO
To investigate the effect of the trial supplement on maker of liver function.
Efficacy
AST : Aspartate Aminotransferase
ALT : Alanine Aminotransferase
Gamma-GT : Gamma-Glutamic Transpeptidase
Point:0w, 4w, 8w, 12w
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Test food contained silymarin and curcumin, 4 tablets once day for 12weeks.
Control food not contained silymarin and curcumin, 4 tablets once a day for 12weeks.
20 | years-old | <= |
65 | years-old | > |
Male and Female
1) Subjects that any one or more of the AST, ALT or gamma-GTP corresponds to criterion of JAPAN SOCIETY OF NINGEN DOCK. However, gamma-GTP of women is half of the value of setting limits.
2)Subjects who giving written informed consent
1)Subjects who are judged as unsuitable for the study by the investigator for AST, ALT, gamma-GTP.
2)Subjects who take drug having an effect on improvement of liver function.
3)Subjects who consecutively take dietary supplement or food including silymarin or curcumin (more than three times a week for more than half year).
4)Subjects who consecutively take dietary supplement or food and can't stop those foods from one week before to the end of the study.
5)Subjects who have allergy to silymarin, (extract of Silybum marianum) or curcumin (extract of Curcuma longa).
6)Subjects who have or had severe disorders (for example, liver function, kidney function, heart function, diabetes etc.) or thyroid disease, adrenal disease and other metabolic diseases.
7)Subjects who have chronic disease and consecutively use drug.
8)Subjects who have excessive drinking habits (apply to the following conditions). More than 100g alcohol consumption per day. More than 80g less than 100g alcohol consumption per day and drinking frequency is five days a week or more. More than 60g less than 80g alcohol consumption per day and drinking frequency is each day.
9)Subjects whose ifestyle is extremely irregular (for exsample, night work, day and night reversed style)
10)Subjects suffer from addiction to the drug or alcohol.
11)Subjects who are planned to participate in other clinical study.
12)Female with pregnancies, lactating or planning to become pregnant during the study.
13)Subjects who are judged as unsuitable for the study by the investigator for other reason.
100
1st name | |
Middle name | |
Last name | Yoshitaka Iwama |
Nihonbashi Cardiology Clinic
Director
13-4 Kodenma-cho, Chuo-ku, Tokyo, Japan
03-5641-4133
yiwama@well-sleep.jp
1st name | |
Middle name | |
Last name | Eiji Yoshikawa |
KSO Corporation
Sales department
1-9-7 Shibaura, Minato-ku, Tokyo, Japan
03-3452-7733
yoshikawa@kso.co.jp
KSO Corporation
FANCL Corporation
Profit organization
NO
医療法人財団健康睡眠会 日本橋循環器科クリニック(Nihonbashi Cardiology Clinic)
2016 | Year | 12 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 07 | Month | 04 | Day |
2016 | Year | 08 | Month | 22 | Day |
2016 | Year | 08 | Month | 03 | Day |
2017 | Year | 02 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027030
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