to alleviate a hangover and promote wakening
Conditions
Interventions
Jingfang Granules - Jingfang granules simulation agent group:Take Jingfang granules in the first cycle and Jingfang granule simulator in the second cycle
Jingfang granule simulator - Jingfang granule group:Take Jingfang granules simulator in the first cycle and Jingfang granule in the second cycle
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) voluntarily participate in the trial and sign the informed consent form before the trial; 2) age 18-60(Including critical values), gender unlimited, healthy subjects; 3) Body mass index (BMI) = [weight kg / (height m) 2] at 19-26 kg / m2; male subjects weight =50.0 kg, female subjects weight =45.0kg; 4) No alcohol consumption within 1 week prior to the first intervention; 5) understand the study requirements and be willing to sign a written informed consent form(ICF) and agree to make the necessary assessment according to the trial requirements.
Exclusion criteria
Exclusion criteria: 1) subjects with known allergy to the ingredients and excipients of Jingfang granules, alcohol allergy, or any drug or food allergy; 2) subjects smoking more than 5 daily averagely(including no smoking during admission); 3) subjects who participated in any other interventional clinical trials within 3 months prior to screening; 4) any prescription drugs, over-the-counter drugs, Chinese herbal medicines and vitamins within 2 weeks before screening; 5) subjects with special requirements for diet and cannot receive a uniform diet; 6) subjects whose vital signs examination, or physical examination, or clinical laboratory tests (blood routine, urine routine, blood biochemistry), or 12-lead electrocardiogram showed abnormalities and have clinical significance, especially with abnormal liver and kidney function; 7) the investigator considers previous or existing diseases or medical history has clinical significance, Including, but is not limited to, the circulatory system, digestive system, nervous system, respiratory system, motor system, endocrine system, urinary system and reproductive system. Especially subjects with digestive diseases such as gastrointestinal dysfunction, peptic ulcer and gastrointestinal surgery; acute diseases before the use of study drugs; 8) subjects with one or more clinically significant tests for hepatitis B surface antigen, hepatitis C antibody, AIDS antibody and treponema antibody; 9) self reported that daily drinking the daily alcohol consumption = 200ml (56 degrees) without drunkenness performance or 25ml liquor (56 degrees) with drunkenness performance(drunkenness performance: different degrees of excitement and excitement, loss of restraint, behavioral abnormalities, talkative and unclear pronunciation, movement and gait disorders, agitation, drowsiness, etc.); 10) alcohol breath test results greater than 0.0mg / 100 mL; 11) history of mental illness, drug abuse, alcohol dependence; 12) surgery within 3 months before screening, or those scheduled to operate during the study; 13) those who donated blood including component blood or substantial blood loss (400 mL), or received blood transfusion or used blood products within 3 months before screening; 14) those who had having a pregnancy or a sperm donation plan during the trial or within 6 months after the trial; 15) women during pregnancy and lactation, or women of childbearing age who do not undergo sterilization surgery/ menopause and are not willing to use medically approved effective contraception during the study; men who did not undergo sterilization surgery and are not willing to use medically approved effective contraception during the study; 16) other subjects judged unsuitable by the investigators to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean blood alcohol concentration (BAC) levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean blood alcohol concentration (BAC) levels;Blood alcohol concentration AUC 0 – 24h after alcohol consumption;The levels of blood ethanol dehydroghydrogenase (enase (ADH) and acetaldehyde deALDH) ;AHS (Acutel Hangover scale);Digital symbol test ;Pursuit aiming test ?;Urination frequency and total urine output from taking medication to 8h after drinking; | — |
Countries
China
Contacts
Public ContactLaichun Lu
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed