ITMCTR2100005316尚未招募4 期
Obstetrics and Gynecology
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 45(—)
- 性别
- Female
入选标准
- •1.Premenopausal women aged 18 = 45;
- •2.Patient is willing to receive drug treatment, and there is no indication of hysteromyoma surgery;
- •3.Uterine leiomyoma leads to menorrhagia (= 80 ml), anemia and compression symptoms, which can meet one of them. Surgical treatment or surgical treatment is refused. Moderate and severe anemia should be included in the group after anemia improvement (HB = 90 g / L);
- •4.FSH< 25 mIU/mL;
- •5.The subjects voluntarily participated in the clinical trial and signed the informed consent form.
排除标准
- •1.Pregnant, menopausal and lactating women and those who are ready to give birth during medication or within 3 months after cessation;
- •2.Submucosal hysteromyoma;
- •3.Patients with endometriosis or adenomyosis;
- •4.Patients who have used gongliuxiao, gongliuning, gongliuqing, Hongjin Xiaojie, Rupi Anxiao and other proprietary Chinese medicines for the treatment of hysteromyoma in recent 1 month;
- •5.Patients who are using contraceptives or taking hormone drugs within 1 month;
- •6.Complicated with severe vaginitis, pelvic inflammation, malignant tumor and other diseases; Patients with serious primary diseases such as cardiovascular, cerebrovascular and hematopoietic systems, psychosis and dementia;
- •7.Poor compliance, unable to cooperate or fail to use drugs according to regulations, and unable to determine the clinical efficacy;
- •8.Participated in other clinical trials within 1 month before participating in this study;
- •9.Allergic constitution or allergic to the test drugs and components;
- •10.Patients with severe liver and kidney diseases and adrenocortical insufficiency, and / or ALT and AST > twice the upper limit of normal value, bun and Cr > the upper limit of normal value;
- •11.Other patients who are not suitable to participate in the clinical trial according to the opinions of the researchers, including the current physical or psychological conditions that make them unable to comply with the protocol.
研究者
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