MedPath

A verification study on effects of alcohol metabolism improvement: A randomized double-blind crossover trial

Not Applicable
Conditions
Healthy Japanese adults
Registration Number
JPRN-UMIN000026356
Lead Sponsor
ORTHOMEDICO Inc.
Brief Summary

akajima N, Toida E, Akaoka K, Yokogawa S, Suzuki N, Fujioka R, Takara T. Effects of a Beverage Containing Powder of Antrodia cinnamomea mycelium and Fermented Grain Extracts on Improving Alcohol Metabolism-A Randomized, Double-blinded, Placebo-controlled, Crossover Trial-. Jpn Pharmacol Ther. 2018; 46(3): 363-373.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
15
Inclusion Criteria

Not provided

Exclusion Criteria

1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Currently taking medicines and/or herbal medicines 5. Those who are allergic to medicines and/or the test food related products 6. Those who are pregnant, breast-feeding, and plan to become a pregnant 7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 8. Others considered as inappropriate for the study by the physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Blood ethanol concentration *Take blood samples before drinking alcohol and at 30, 60, 120, and 180 minutes after *Implement after each single-dose (total 4 times)
Secondary Outcome Measures
NameTimeMethod
1. Blood acetaldehyde concentration * Take blood samples before drinking alcohol and at 30, 60, 120, and 180 minutes after *Implement after each single-dose (total 4 times) 2. Questionnaire of subjective symptoms (The Likert scale method) *Fill in the questionnaire 180 minutes after drinking alcohol *Implement after each single-dose (total 4 times)
© Copyright 2025. All Rights Reserved by MedPath