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临床试验/ITMCTR1900002360
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

发起方
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

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