Uterine leiomyoma
Conditions
Interventions
group A:Xiaozheng pill
group B :Guizhi Fuling Capsule
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Premenopausal women aged 18 to 45 years; 2. The patient is willing to accept drug treatment, and there is no indication for uterine fibroids surgery; 3. Uterine fibroids cause menorrhagia (>= 80 ml), anemia, and compression symptoms, etc., and one of them can be met, and those who refuse surgical treatment or are contraindicated in surgical treatment. Moderate and severe anemia should be enrolled after anemia improvement (Hb >= 90 g/L); 4. FSH < 25 mIU/mL; 5. The subjects voluntarily participated in the clinical trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, menopause and lactating women and those who are ready to give birth during the medication or within 3 months after stopping; 2. Submucosal uterine fibroids (because submucosal fibroids are most likely to cause bleeding, the clinical manifestations are more bleeding, and it is difficult to control the bleeding symptoms quickly with drug treatment, surgery is generally used, so it is excluded); 3. Combined with endometriosis or adenomyosis; 4. Patients who have used Gongliuxiao, Gongluning, Gongliuqing, Hongjinxiaojie, Rupianxiao and other Chinese patent medicines for the treatment of uterine fibroids within the past 1 month; 5. Patients who are using contraceptives or taking hormone drugs within 1 month; 6. Combined with severe vaginitis, pelvic inflammatory disease, malignant tumor and other diseases; patients with serious primary diseases such as cardiovascular and cerebrovascular, hematopoietic system, mental illness and dementia; 7. Those with poor compliance, unable to cooperate or not taking medication as prescribed, and unable to determine clinical efficacy; 8. Those who have participated in other clinical trials within 1 month before participating in this study; 9. Allergic constitution or allergic to the test drugs and ingredients; 10. Patients with severe liver and kidney disease and adrenal insufficiency, and/or ALT, AST > 2 times the upper limit of normal, Bun and Cr > upper limit of normal; 11. Other patients who are not suitable to participate in clinical trials according to the opinion of the investigator, including the existing physical or psychological conditions that make them unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume of uterine fibroids; | — |
Countries
China
Contacts
Public ContactWang Shixuan
Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed