Adenomyosis
Conditions
Interventions
control group:Oral administration of levonorgestrel
Experimental group:Tongmai Huazheng mixture
Sponsors
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
Female
Age
22 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the Western medical diagnostic criteria for adenomyosis; (2) Meeting the TCM syndrome differentiation criteria for yang deficiency and blood stasis syndrome; (3) The highest Visual Analogue Scale (VAS) score for dysmenorrhea symptoms during the last menstrual period before enrollment is = 40mm; (4) Aged between 22 and 50 years old, with no fertility needs in the recent six months; (5) Menstrual cycles are all around (28 ± 7) days; (6) Ultrasonography shows varying degrees of uterine enlargement, uneven echo in the uterine myometrium, asymmetric thickening of the anterior and posterior uterine walls, no obvious boundary between the lesion and the surrounding area, unclear boundary between the endometrium and the myometrium, and anterior displacement of the endometrial line; (7) Those who agree to participate in this trial and signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients who have used steroids and similar medications for the treatment of this disease within one month prior to enrollment; (2) The maximum diameter of the uterine body on the last intracavitary ultrasound before enrollment is greater than 10.0 cm; (3) Acute pelvic inflammatory disease intrauterine adhesions pelvic tuberculosis abnormal uterine bleeding or highly suspected malignant tumor patients with endometrial lesions; (4) Merge with other similar diseases such as endometrial polyps with a diameter greater than 1cm individual uterine fibroids with a diameter greater than 4cm and adnexal cysts with a diameter greater than 4cm; (5) Patients with serious primary diseases such as heart cerebrovascular liver kidney and hematopoietic system diabetes thyroid disease and psychosis; (6) Hemoglobin concentration<90g/L; (7) Blood creatinine exceeds the upper limit of normal values or alanine aminotransferase and either aspartate aminotransferase exceeds the upper limit of normal values by 1.5 times; (8) Pregnant or lactating women; (9) Individuals with allergic constitution as well as those who are allergic to alcohol and related ingredients of this medicine; (10) Participated in other clinical studies within the past month; (11) Individuals who require frequent use of painkillers due to other underlying illnesses; (12) Suspecting or confirming a history of alcohol addiction or drug abuse or other lesions or conditions that based on the researcher's judgment reduce the likelihood of inclusion or complicate inclusion such as frequent changes in work environment unstable living environment etc. which can easily lead to loss of follow-up; (13) Researchers believe that participants are not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Score;Quality of Life Score;PBAC score;Hemoglobin levels;Uterine volume;Usage of Ibuprofen;COX score;Area under the pain time curve;Recurrence rate of dysmenorrhea;Serum CA125 level;Serum HLA level; | — |
Countries
China
Contacts
Public ContactWei Shi
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Outcome results
None listed