uterine fibroids
Conditions
Interventions
Ruanjian Sanjie Group:Ruanjian Sanjie Capsule combined with High Intensity Focused Ultrasound Treatment
control group:only treated with High Intensity Focused Ultrasound Treatment
Sponsors
Shanxi Province hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) In line with the diagnostic criteria written by "new Chinese medicine for the treatment of uterine fibroids clinical research guidelines" (2002,5:239) promulgated by Ministry of Health issued by the People's Republic of China and standards of TCM Syndrome Differentiation; (2) Hormone therapy was not used in the past 3 months; (3) Preoperative ultrasound localization examination can find the definite, and the maximum diameter of the myoma >1cm, so as to establish the appropriate ultrasonic channel; (4) If we have pedicle myoma, the width of the pedicle should be greater than 1/2 of the diameter of the myoma. (5) The skin of the treatment area is intact, the surface tissue is free of ulceration, infection, etc.; (6) The body is in good condition, with no strict cardiac, hepatic, renal dysfunction and mental abnormality, and can actively cooperate with the treatment; (7) Non menopausal women, non pregnant women; (8) Patients and relatives should be informed consent, and request HIFU treatment.
Exclusion criteria
Exclusion criteria: (1) Allergic to Ruanjiansanjie capsule; (2) Allergic to operative medication such as midazolam, fentanyl and so on; (3) Combined with severe damage to the heart, liver and kidney or poor control of hypertension; (4) Combined with severe vaginitis, pelvic inflammatory disease, malignant tumor and other diseases; (5) The patients general situation is bad and unable to tolerate or adhere to the HIFU treatment; (6) The contraindication of ultrasonic focused therapysuch as unclear tumor display or ultrasonic treatment of channel is obstructive, or we can not avoid important organs, such as scars, and still can not get enough acoustic channels after auxiliary treatment; (7) Patients who had withdrawn or lost contact for various reasons during the follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume ablation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Uterine fibroids symptom severity;hemoglobin; | — |
Countries
China
Contacts
Public ContactGao Jinsheng
Shanxi Province hospital Research Institute of Traditional Chinese Medicine
Outcome results
None listed