Effect of continuous ingestion of trial supplement on liver function. - A randomized, placebo-controlled, double-blind, parallel-group clinical trial
- Conditions
- Healthy volunteer
- Registration Number
- JPRN-UMIN000023459
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AST : Aspartate Aminotransferase ALT : Alanine Aminotransferase Gamma-GT : Gamma-Glutamic Transpeptidase Point:0w, 4w, 8w, 12w
- Secondary Outcome Measures
Name Time Method