Effects of an herbal medicine for the metabolism of alcohol

JRCT ID: jRCTs031220307

Registered date:31/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: status of drunkenness
• Date of first enrollment: 31/08/2022
• Target sample size: 16
• Countries of recruitment: note,Japan
• Study type: Interventional
• Intervention(s): medication

Outcome(s)

• Primary Outcome: Blood alcohol concentration after drinking alcohol
• Secondary Outcome: Subjective symptoms and breath alcohol concentration after drinking

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1. The person who can drink 360ml of Japanese sake and do not show physical deconditioning after the drinking
2. No abnormal findings on health examination, no past histories of diseases such as digestive organ, liver, kidney, and the respiratory organ
3. No serious diseases are begin treated
4. Informed consent by a document is obtained from the person himself

Exclude criteria

1. The person who cannot regulate the amount or frequency of drinking alcohol
2. The person who regularly takes medicines, such as antiallergic drugs, digestive drugs and any supplement
3. The person who has experiences of physical deconditioning after the small amount of drinking alcohol (e.g. 500ml beer or 180ml Japanese sake)
4. The person who had past histories of health hazards caused by drinking alcohol
5. The person who has an allergy to medicine to be tested
6. The person who the doctor in charge judged that he is not suitable for a participant

Related Information

• Primary Sponsor: Namiki Takao
• Secondary Sponsor: JPS Pharmaceutical Co Ltd