A multi-center randomized controlled clinical study of HIFU combined with Guizhi Poria Capsule in sequential treatment of uterine fibroids
- Conditions
- intramural uterine fibroids, IUF
- Registration Number
- ITMCTR2100005040
- Lead Sponsor
- Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
1. Aged 20 to 49 years, regular menstrual cycle, 21-35 days;
2. Those who meet the IUF diagnostic criteria and the diameter of fibroids is <=8cm and >=3cm;
3. Those who meet the conditions of HIFU treatment and receive HIFU treatment;
4. Those who have no requirement for childbirth during treatment;
5. Subjects gave informed consent and signed an informed consent form voluntarily.
1. Those who are allergic to the relevant drug ingredients in this study;
2. Patients with severe primary diseases and mental illnesses such as severe heart, cerebrovascular, liver, kidney and hematopoietic system, diabetes, and thyroid diseases;
3. Submucosal fibroids, subserosal fibroids, adenomyosis, adenomyoma, and malignant transformation;
4. Those who have participated in other clinical researches within the past month, or are using similar drugs and related treatments within one month, and the efficacy of the drugs is difficult to judge;
5. The investigator believes that it is not suitable to participate in this clinical research.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method terine size;Chinese Medicine syndrome score;Uterine fibroids size;
- Secondary Outcome Measures
Name Time Method terine Fibroids Symptoms and Health-Related Quality of Life Questionnaire;