primary dysmenorrhea
Conditions
Interventions
low -dose group (12 capsules):Single dose
Medium-dose group (18 capsules):single dose
High dose group (24 capsules):single dose
Continuous dosing group:The single dose was administered on the first day of the trial and from the fourth day of the trial it was administered twice a day for 7 consecutive days
Sponsors
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1)Male or female aged 18~45 years (including 18 and 45 years old); 2)Weight: males weighing not less than 50kg and females weighing not less than 45kg with body mass index (BMI) = [weight kg/(height m)2] between 19 and 26 including borderline values; 3)Good health (no significant clinical symptoms normal physical examination no clinically significant abnormal laboratory and electrocardiogram liver spleen or kidney ultrasound findings); 4)Agree and take effective contraceptive measures during the trial and for 3 months after the trial to avoid conception of the spouse or himself/herself; 5) Voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1)Women who are lactating or pregnant; 2)Those with heart liver or kidney diseases or acute or chronic digestive or respiratory diseases as well as those with a history of hematologic endocrine neurological or psychiatric disorders or any other disease or physiological condition capable of interfering with the test results; 3)History of dysmenorrhea within the last 2 years; 4)Resting state heart rate below 50 beats/min or above 100 beats/min by repeated measurements; 5) clinically relevant pathologic abnormalities seen on the ECG including P-R intervals >250 milliseconds QRS time limits >120 milliseconds and QTcF >450 milliseconds in women or QTcF >430 milliseconds in men; 6)Allergy such as those who are allergic to one or more drugs or foods; or those who are known to be allergic to the components or excipients of this drug; 7)Persons who are positive for hepatitis B surface antigen or hepatitis C antibody or HIV antibody or syphilis antibody; 8) those who have a positive pregnancy test; 9)Those with a history of prior drug abuse or a positive drug abuse test (including morphine methamphetamine ketamine tetrahydrocannabinolic acid methylenedioxymethamphetamine); 10)Alcohol intake in the 3 months prior to dosing who consumed more than 14 units of alcohol per week (1 unit = 360mL of beer or 45mL of spirits of 40% alcohol by volume or 150mL of wine) or who were unable to abstain from alcohol for the duration of the trial or who tested positive for alcohol; 11)Persons who smoked =5 cigarettes/day or used an equivalent amount of nicotine products within 3 months prior to dosing or who were unable to quit smoking during the trial; 12)Persons who have undergone major surgical procedures within 4 weeks prior to dosing and persons who have received blood or blood component transfusions; 13)Those who have lost or donated more than 400 ml of blood within 3 months prior to drug administration; 14)Those who have participated in other clinical trials within 3 months prior to administration; 15)Those who have taken any Chinese or Western medication within 2 weeks prior to drug administration; 16)Those who refused to stop taking medicinal diets or foods containing cinnamon sticks or cinnamon bark or cinnamon or poria or peach kernel 2 weeks prior to administration of the test drug until the end of the trial; 17)Those who refuse to stop intake of food or drink containing xanthine (e.g. caffeine chocolate tea) 48 hours before taking the trial drug until the end of the trial; 18)Those who refuse to stop consuming grapefruit or grapefruit products limes poppies or any food or drink containing such ingredients 2 weeks prior to taking the test drug until the end of the trial; 19)Those who refuse to stop consuming intestinal flora modifiers (e.g. probiotics yogurt) 2 weeks prior to taking the test drug until the end of the trial; 20)Persons who have difficulty swallowing capsules or taking blood intravenously; 21) any subject who in the judgment of the investigator has a reduced likelihood of enrollment (e.g. frailty etc.) has a tendency to be noncompliant during the study or has other pathologies that complicate enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-8;Cmax;AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rac;Vd;Tmax;F;t1/2;CL; | — |
Countries
China
Contacts
Public ContactMin He
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Outcome results
None listed