ITMCTR1900002360招募中1 期
Chinese Herbal Medicines for Menopausal Symptoms in Breast Cancer Patients: A Randomized, Double-blind, Controlled Study
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine0 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
- 25 至 60(—)
- 性别
- Female
入选标准
- •? Patients with primary breast cancer (stage 0-III) by pathologic diagnosis and with menopausal symptoms;
- •? Aged 25-60 years;
- •? Patients are undergoing endocrine therapy for more than 3 months;
- •? The subjects experienced at least 4 times of moderate and severe hot flashes every day;
- •? The Karnofsky score is greater than or equal to 60 points;
- •? The predicted survival time is greater than or equal to 6 months;
- •? Voluntarily sign the informed consent file.
排除标准
- •? Patients with recurrent, metastatic breast cancer or other cancer diagnosed by imaging or histology;
- •? Patients who cannot adhere to endocrine therapy;
- •? Uncontrolled and/or diagnosed medical conditions such as severe liver, kidney, heart, and brain diseases; abnormal bone marrow function; Uncontrolled or untreated hypertension (SBP >160mmHg and/or DBP > 100mmHg), Uncontrolled or untreated diabetes; Or abnormal thyrotropin may lead to symptoms similar to menopausal symptoms.
- •? Pregnant and lactating women;
- •? Participated in phase I and II clinical trials in the past 6 months or participated in phase III and IV clinical trials in 3 months;
- •? Use other medications (e.g. tibolone, black cohosh extract or soy isoflavones, vitamins, etc.) for menopausal symptoms within 3 months;
- •? Allergic to the tested drug.
研究者
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