Abnormal uterine bleeding (menorrhagia)
Conditions
Interventions
Sponsors
Beijing Chinese Medicine Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: The following criteria must be fully met before they can be included: (1) It meets the diagnostic criteria for chronic abnormal uterine bleeding in Western medicine. (2) According to FIGO's "PALM-COEIN" system classification method, it is judged to be abnormal uterine bleeding - ovulation disorder (O), abnormal uterine bleeding - adenomyosis (A), abnormal uterine bleeding - endometrial polyps (P) Abnormal uterine bleeding - uterine leiomyoma (L), menorrhagia caused by placement of the IUD. (3) The diagnosis of bleeding pattern is more menorrhagia: more menstruation during the screening period (2 or more in the screening period, and the total score of menstrual blood loss in the 7 days is >= 100 points). (4) Comply with the syndrome differentiation standard of Chinese medicine blood stasis syndrome. (5) Regular menstrual cycle, menstrual cycle >= 21 days and = 3 days and <= 7 days. (7) Women aged 18 to 45 years (including 18 and 45 years old). (8) Willing to use and collect the sanitary protection products (sanitary napkins) provided by the sponsor throughout the study. (9) Those who voluntarily participate in the experimental study and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: The following standards must all be inconsistent to be included: (1) congenital dysplasia of the reproductive system or pelvic B-ultrasound (transabdominal) suggesting that it is not suitable for clinical trials (including but not limited to submucosal fibroids or uterine fibroids >= 3 cm in diameter, endometrial polyps > 1 cm in diameter) or require surgery Or minimally invasive treatment, or suspected of having a malignant tumor of the reproductive system. (2) Uterine bleeding caused by pregnancy. (3) Hemoglobin (Hb) <= 80g / L. (4) The combination of cardiovascular, hepatic, renal, endocrine, blood and other systemic primary diseases, the degree is serious, the researchers judged that it is not appropriate to participate in this clinical trial. (5) If ALT and/or AST are greater than 1.5 times the upper limit of the normal range, and Scr is greater than the upper limit of the normal range. (6) Those with abnormal blood coagulation and clinical significance. (7) Take Chinese medicine with similar functions and intensive treatment within 4 weeks, and have vaginal or oral estrogen or estrogen and progesterone treatment within 12 weeks. (8) Those who are using or need to use thrombin in clinical trials. (9) Breastfeeding, pregnancy, and planning for pregnancy within 6 months. (10) Those who are known to be allergic to the test drug composition. (11) Those who are unable to cooperate with or are unwilling to cooperate with nerves, mental disorders, etc. (12) Those who have a history of alcohol dependence and drug abuse. (13) Those who have participated in other clinical trials within 12 weeks prior to the participation or trial. (14) Others are not suitable to participate in this clinical trial according to the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in menstrual blood loss (MBL) relative to baseline; | — |
Countries
China
Contacts
Public ContactTeng Xiuxiang
Beijing Chinese Medicine Hospital affiliated to Capital Medical University
Outcome results
None listed