Uterine fibroids
Conditions
Interventions
Research Group:Xiao Ai Flying Honey Ointment
Sponsors
Xinjiang Uyghur Autonomous Region Uyghur Medical Hospital (Xinjiang Uyghur Autonomous Region Second People's Hospital)
Eligibility
Sex/Gender
Female
Age
22 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for uterine fibroids in Western medicine; (2) Meets the diagnostic criteria for gongliu disease in Uyghur medicine; (3) Age is between 22 and 50 years (including boundary values) with a history of sexual activity; (4) The maximum diameter of uterine fibroids is =4 cm; (5) No severe comorbidities, and the individual requests conservative treatment; (6) Voluntarily participates in this study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with cervical lesions, anemia: hemoglobin =9g/dL (or 90g/L), coagulation disorders, or perimenopausal individuals; (2) Uterine body size exceeding 3 months of gestation, or patients with leiomyoma degeneration; (3) Patients diagnosed with suspected uterine adenomyosis or other masses via ultrasound and gynecological examination, or undiagnosed uterine leiomyomas; (4) Patients with indications for surgery, including submucosal myomas, parasitic myomas, etc.; (5) Patients with liver diseases such as alcoholic liver disease, infectious liver disease, drug-induced liver injury, or autoimmune liver disease, or those with tuberculosis or tumors; (6) Patients with abnormal liver and kidney function laboratory indicators: ALT, AST =1.5 times the upper limit of normal, SCr exceeding the upper limit of normal; (7) Patients who have used Western medicine (e.g., mifepristone) to treat this condition within the past 3 months, or have taken oral contraceptives for contraception, or have received estrogen or progestogen therapy for other diseases, or have used Uighur medicine, Chinese medicine, or traditional Chinese medicine preparations to treat this condition within the past month; (8) Patients with progesterone intrauterine devices, or those who have had progesterone-containing intrauterine devices removed within the past 3 months; (9) Patients who have undergone uterine myomectomy, uterine artery embolization, high-intensity focused ultrasound (HIFU) ablation, or medical abortion or termination of pregnancy within the past 3 months; (10) Pregnant or breastfeeding women, those planning pregnancy during the study period, unwilling to use condoms as a contraceptive measure during the study, or women with plans for pregnancy within the past 6 months; (11) Patients with a history of allergy to the components of the investigational drug; (12) Patients with any history of disease that may affect compliance with the protocol (e.g., severe mental disorders, cognitive impairments, drug abuse or addiction, chronic alcoholism, etc.); (13) Patients who have participated in other drug or medical device clinical studies within the past month; (14) Other situations deemed unsuitable for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in clinical symptom scores for uterine fibroids compared to baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in clinical symptom scores and individual symptom scores compared to baseline for uterine fibroids.;Clinical symptom scores for uterine fibroids and disappearance rate of individual symptom scores.;The change in the volume of the largest uterine fibroid from baseline.;Changes and disappearance rates of Uyghur medical syndromes from baseline and changes and disappearance rates of individual syndromes from baseline.;Changes in Symptoms of Uterine Fibroids and Health-related Quality of Life Questionnaire (UFS-QOL) Compared to Baseline;The incidence of surgery for uterine fibroids.;The change in sanitary napkin usage quantity compared to baseline.;The mean change in menstrual color score from baseline.;The change in hemoglobin level compared to baseline.;Change in the number of uterine fibroids from baseline;Changes in sex hormone levels compared to baseline.;Uterine Leiomyoma Recurrence Rate; | — |
Countries
China
Contacts
Public ContactNilufar Setiwaldi
Xinjiang Uyghur Autonomous Region Uyghur Medical Hospital (Xinjiang Uyghur Autonomous Region Second People's Hospital)
Outcome results
None listed