adenomyosis
Conditions
Interventions
Experimental Group:Oral Tongmai Huazheng Mixture
Control Group:Oral Tongmai Huazheng Mixture Simulant
Sponsors
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
Female
Age
22 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Meets the Western medical diagnostic criteria for adenomyosis of the uterus; (2) Meets the diagnostic criteria for Yang deficiency and blood stasis syndrome in Traditional Chinese Medicine; (3) The highest Visual Analog Scale (VAS) score for dysmenorrhea symptoms during the last menstrual period before enrollment is = 40mm; (4) Age is between 22 and 50 years old, with no plans for pregnancy in the past six months; (5) Menstrual cycle is (28±3) days; (6) Menstrual duration is =7 days; (7) Ultrasound shows varying degrees of uterine enlargement, heterogeneous echoes in the uterine muscle layer, asymmetric thickening of the anterior and posterior walls of the uterus, no clear boundaries between the lesion and the surrounding tissue, unclear demarcation between the endometrium and the muscle layer, and anterior displacement of the endometrial line; (8) Voluntarily agrees to participate in this study and provides informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients who have used hormones or similar drugs for the treatment of this disease within 1 month prior to enrollment; (2) Patients whose uterine body maximum diameter, as measured by intra-cavity ultrasound, was greater than 10.0 cm at the last measurement prior to enrollment; (3) Patients with acute pelvic inflammation, uterine cavity adhesions, pelvic tuberculosis, abnormal uterine bleeding, or endometrial lesions highly suspected of being malignant tumors; (4) Patients with other similar conditions: such as endometrial polyps larger than 1 cm in diameter, single uterine fibroids larger than 4 cm in diameter, or ovarian cysts larger than 4 cm in diameter; (5) Patients with severe primary diseases such as serious heart, brain, vascular, liver, kidney, or hematopoietic system disorders, diabetes, thyroid diseases, or mental illness; (6) Patients with a hemoglobin concentration <80 g/L; (7) Patients with serum creatinine exceeding the upper limit of normal or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 1.5 times the upper limit of normal; (8) Pregnant or breastfeeding women; (9) Patients with a history of allergies, or allergies to alcohol or any components of this medication; (10) Patients who have participated in other clinical studies within the past 1 month; (11) Patients who require frequent use of analgesics due to other underlying diseases; (12) Patients with a suspected or confirmed history of alcohol addiction or substance abuse, or other conditions that may reduce the likelihood of enrollment or complicate participation, as determined by the investigator, such as frequent changes in work environment or unstable living conditions that may lead to loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Score;Pictorial Blood Loss Assessment ChartRating;Hemoglobin level;Uterine volume;Ibuprofen Usage;COX menstrual symptom scale;Pain-Time Under Curve Area;Dysmenorrhea recurrence rate;Serum CA125 level; | — |
Countries
China
Contacts
Public ContactShi Wei
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Outcome results
None listed