ITMCTR2000003768招募中1 期
Moxibustion combined with herbs for the prophylactic and therapeutic use of joint pain caused by aromatase inhibitors in postmenopausalbreast cancer: a randomized controlled trial
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 45 至 75(—)
- 性别
- Female
入选标准
- •1. All patients were meet the pattern identification criteria of TCM and diagnostic criteria of western medicine;
- •2. Patients must be postmenopausal female;
- •3. Aged from 45 to 75 years;
- •4. Pathological investigations confirmed a primary invasive breast cancer;
- •5. According to the pathological results and the physical condition, all patients were required to take AI with breast cancer guidelines of CBCSG (version 2019);
- •6. Patients who have taken AI for at least three months ;
- •7. Patients who have joint pains during taking AI and the score about BPI-SF > 4;
- •8. Be willing to participate in clinical trials and be able to cooperate with regular follow-up;
- •9. All patients must have signed and dated an informed consent form.
排除标准
- •1. Recurrent and metastatic breast cancer;
- •2. Severe liver and kidney dysfunction (AST/SGOT or ALT/AGPT is > 2.5 times of the ULN, and Serum Cr is >= 150umol/L);
- •3. Severe heart dysfunction other organ failure;
- •4. Any previous or concurrent primary malignancy;
- •5. A history of fracture or joint surgery within 6 months;
- •6. Patients who had used traditional Chinese medicine, moxibustion treatment or other TCM related treatment for AIA in the past 3 months;
- •7. Participating in other clinical trials within 3 months;
- •8. In any reason that cannot cooperate with the study, such as language understanding, unable to refer to the research center, etc.;
- •9. Other conditions or diseases that may be excluded from the study that may result in significant risk or confusion in the study;
- •10. Previous use of NSAIDs and opioid analgesics.
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