Adenomyosis
Conditions
Interventions
High Dose of Traditional Chinese Medicine Group:High dose of Wenyang Huoxue Granules
Low Dose of Traditional Chinese Medicine Group:Low dose of Wenyang Huoxue Granules
Placebo Group:Simulated dose of Wenyagn Huoxue Granules
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. In line with Western diagnostic standards for adenomyosis; 2. Conforming to the TCM standard for syndrome differentiation of cold coagulation and blood stasis; 3. People aged between 18 and 50 with regular menstrual cycles (28±3 days); 4. Visual analog scale (VAS) of dysmenorrhea for last menstrual period before enrollment >=40 mm; 5. Sign informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients with undiagnosed abnormal uterine bleeding or endometrial lesions, acute pelvic inflammatory disease, uterine adhesion, and pelvic tuberculosis; 2. Patients receiving hormonal drugs in the last 3 months, including oral contraceptives, Mirena, GnRH-a, progesterone, etc.; Patients who have received TCM treatment for adenomyosis in the past 1 month; 3. Last intrauterine ultrasound before enrollment, the maximum diameter of uterine in intrauterine ultrasound is greater than 10.0 cm; 4. Dysmenorrhea caused by other reasons, such as endometriosis, a single uterine fibroid with a diameter greater than 4cm, etc.; 5. Hemoglobin concentration < 90 g/L; 6. Serum creatinine exceeds the upper limit of normal value or any item of ALT or AST exceeds 1.5 times the upper limit of normal value; 7. Patients who plan to become pregnant during pregnancy or within half a year, breastfeeding patients; 8. Patients with serious primary diseases such as heart, cerebrovascular, liver, kidney and hematopoietic system, diabetes, thyroid diseases and mental diseases; 9. Allergic constitution, and allergic to related ingredients of this medicine; 10. Participate in other clinical researchers within 1 month; 11. Patients who need to take painkillers regularly due to other underlying medical conditions; 12. Suspected or confirmed history of alcohol addiction or drug abuse, or other diseases or conditions that, according to the researchers' judgment, reduce or complicate the possibility of enrollment, such as frequent changes in the working environment or unstable living environment, which could easily lead to loss of follow-up; 13. Those who were deemed unsuitable to participate in the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dysmenorrhea visual analogue score;Dysmenorrhea COX score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of TCM symptoms;Efficacy of single symptoms of TCM;Menstrual blood loss score;The size of the uterus;The size of adenomyosis leision;The level of serum CA125;The level of serum CA199;Recurrence rate of dysmenorrhea;Score of life quality;The level of hemoglobin; | — |
Countries
China
Contacts
Public ContactZhao Ruihua
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed