primary dysmenorrhea
Conditions
Interventions
experimental group:Started 10 days (±3 days) before the onset of menstruation Guizhi Fuling Capsules twice daily on the second day of menstruation (±1 day) the patient took a single dose of Guizhi Ful
Sponsors
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1) Compliance with the Western diagnosis of primary dysmenorrhea; 2) An NRS score of =5 for the most painful abdominal pain before or during each menstrual cycle for the 3 menstrual cycles prior to screening; 3)Regular menstrual cycles (26-31 days) with a 3-7 day menstrual period in the 3 menstrual cycles prior to screening; 4)Females aged 18-35 years (inclusive of 18 and 35 years); 5)Voluntarily participate in this clinical trial give informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) secondary dysmenorrhea caused by combined endometriosis adenomyosis pelvic inflammatory diseases uterine fibroids >5cm ovarian cysts >5cm congenital anatomical abnormalities or other pelvic diseases; 2)History of abortion colposcopy colposcopic biopsy and other procedures that cause dysmenorrhea (except if they do not cause secondary dysmenorrhea); 3)Use of herbs and their preparations within 2 weeks prior to screening; 4)A history of disease or illness that may affect the in vivo process of the study drug and who in the judgment of the investigator are not suitable for enrollment in this study; 5)Use of injectable or subcutaneous implants of long-acting contraceptives within 6 months or use of contraceptive pills within 8 weeks or use of a medicated intrauterine device (IUD) prior to screening; 6)Those with previous or current serious diseases of the cardiovascular cerebral pulmonary hepatic renal neurological hematopoietic and gastrointestinal systems which in the judgment of the investigator make enrollment in this study unsuitable; 7)Have mental retardation or psychiatric disease or neurosis; 8)known or suspected history of allergy to the components of the test drug and its excipients; 9)allergy or contraindication to the emergency drug ibuprofen capsules; 10)Pregnant or lactating women who are unable to use contraception during the test period or who plan to become pregnant within 3 months after the end of the test; 11)Those who are positive for Hepatitis B surface antigen or Hepatitis C antibody or HIV antibody or syphilis antibody; 12)Those who have a positive pregnancy test; 13)Those with a history of prior drug abuse or a positive drug abuse test (including morphine methamphetamine ketamine tetrahydrocannabinolic acid methylenedioxymethamphetamine); 14)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; 15)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; 16)Persons who have undergone major surgical procedures within 4 weeks prior to dosing and persons who have received blood or blood component transfusions; 17)Persons who have received antibiotic therapy within 2 weeks prior to dosing; 18)Those who have lost or donated more than 400 ml of blood within 3 months prior to the administration of the drug; 19)Those who have participated in other clinical trials within 3 months prior to administration of the test drug; 20)Those who refused to stop taking medicinal diets or foods containing cinnamon sticks or/and cinnamon bark or/and cinnamon or/and poria or/and peach kernel 2 weeks prior to administration of the test drug until the end of the trial; 21)Those who refuse to stop taking food or drinks containing xanthine (e.g. caffeine chocolate tea) 48h before taking the test drug until the end of the trial; 22)who refused to stop consuming grapefruit or grapefruit products limes poppies or any food or drink containing such ingredients 2 weeks before taking the test drug until the end of the trial; 23)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; 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;AUC0-8;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| t1/2;Vd;CL;Tmax;F;Rac; | — |
Countries
China
Contacts
Public ContactQinhua Zhang
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Outcome results
None listed