Uterine leiomyoma
Conditions
Interventions
Experimental group 1:Gongliuning tablets plus Mlfepristone
Control group(group C):Mifepristone
Experimental group 2:Gonglouning tablets
Sponsors
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Comply with the diagnostic criteria of uterine fibroids, B-ultrasound and gynecological examination are used to determine the mean diameter of maximum fibroids (transverse diameter + longitudinal diameter/2): 2-5 cm intramural uterine fibroids, subserosal uterine fibroids, incomplete submucosal uterine fibroids, requiring medication; 2) Those who meet the dialectical criteria of TCM qi stagnation and blood stasis syndrome; 3) Women aged 18 to 50 years without menopause; 4) Uterine fibroids causing menorrhagia (>=80ml), anemia and compression symptoms, meet one of them,and those people who refuse surgery or have surgery contraindications. Patients with moderate to severe anemia were required to receive anemia treatment (Hb >=90 g/L); 5) There was no obvious abnormality in cervical screening (TCT) within one year; 6) Volunteers who have signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with indications for uterine fibroid surgery and who are willing to undergo surgery; 2) Complete submucosal uterine fibroids; 3) Pregnant or lactating women; 4) Postmenopausal uterine fibroids; 5) Patients with suspected adenomyosis or other tumors diagnosed by B-ultrasound and gynecological examination; 6) Those with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system and coagulation system; 7) Patients who may be allergic to the ingredients of this preparation; 8) Combine other medications those are used for uterine fibroids; 9) Patients with mental illness; 10) A history of treatment for sex hormones within one month; 11) Those who have received other treatment for this disease within the past three months; 12) Those who have participated in other clinical drug trials in the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uterus and fibroid size; | — |
Secondary
| Measure | Time frame |
|---|---|
| hemoglobin;FSH, LH, estradiol, progesterone, testosterone, prolactin;Dysmenorrhea, pelvic compression symptoms, menorrhagia, prolonged menstruation, etc; | — |
Countries
China
Contacts
Public ContactXiangyan Ruan
Gynecological endocrine Department, Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Outcome results
None listed