uterine fibroid
Conditions
Interventions
Experimental:orally 3 capsules once, three times daily, with a treatment course of 3 months(menstruation period suspended). All are after meal
control:Placebo capsules,orally 3 capsules once, three times daily, with a treatment course of 3 months(menstruation period suspended). All are after meal
Sponsors
West China Second University Hospital, Sichuan University
Eligibility
Sex/Gender
Female
Age
25 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Pre-menopause patients who were diagnosed as having uterine firbroid by gynecological examination and transvaginal color ultrasonography; 2. Female aged 25-45 who had sex intercourse; 3. Maximum diameter >=2.5cm, <=5cm; uterine volume <=10 weeks pregnant; 4. The mount of the menstruation exceeded more than 1/3 pre-menstrual blood volume; or patients who wanted an treatment without menorrhagia; 5. Patients who did not use the related drugs within 3-month before enrollment or had no pregnancy history; 6. Aminotransferase <1.5 times of the upper normal limit; normal renal function; 7. All volunteers signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients complicated with adenomyosis or endometriosis that were suspected or diagnosed by ultrasound or gynecologic examination; 2. Suspected or identified as other malignant tumors of genital tract, such as cervical cancer, carcinoma of endometrium and ovarian cancer; 3. Pregnancy, lactation or postmenopause; 4. Planned pregnancy with in 6 months; 5. Female with IUD for contraception; 6. Patients complicated with serious illness, such as gastrointestinal, cardiovascular, liver, renal and hematopoietic disease; 7. Myoma at special locations, such as submucous myoma, pedicled subserous myoma, cervical myoma and so on; 8. Disordered menstrual cycle that is more than 40 days or less than 20 day; menstrual period > 7 days; 9. Underwent surgery to therapy myoma previously; 10. Uterine firbroid examination showed rich blood flow, denatured myoma or CA125 increasing; 11. Hemoglobin < 90g/L; 12. Heat syndrome in Chinese medicine: oral erosion, feverish palms or soles, burning sensation of five areas, red lip, red tongue with yellow or no tongue coating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| quality of life;the size of uterine fibroids reduce; | — |
Secondary
| Measure | Time frame |
|---|---|
| the requirement of other adjunctive therapies, such as hemostatic, chalybeate; | — |
Contacts
Public ContactMingrong XI
Outcome results
None listed