A randomized, double-blind, cross-over clinical trial of Sinisan in improving depression state of breast cancer patients with mild to moderate depressio
- Conditions
- mild to moderate depression of Breast cancer patients
- Registration Number
- ITMCTR2200006710
- Lead Sponsor
- Zhiyu Wang
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
(1) Pathologically diagnosed breast cancer patient, in line with clinical diagnosis of breast cancer;
(2) 18 years to 75 years old;
(3) Combined with PHQ -9 and Hamd -24, the patients were diagnosed as mild to moderate depression by psychologists;
(4) Theoretically Diagnosed stagnation of liver-qi syndrome of Traditional Chinese medicine;
(5) ECOG=2;
(6) Be able to understand the questions in the scale and complete it;
(7) Volunteer to participate in the clinical study and sign the informed consent.
(1) Pregnant or lactating women;
(2) Patients with history of other malignant tumors;
(3) Patients with diagnosed major depressive disorder;
(4) Patients with cardiovascular diseases , liver and kidney dysfunction and other serious diseases;
(5) Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing history;
(6) patients who used antidepressant, antipsychotics or accept any form of psychological treatment within 2 weeks before treatment;
(7) patients who were participating in other clinical trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depression scores as assessed by HAMD-24;
- Secondary Outcome Measures
Name Time Method Depression scores as assessed by PHQ-9;Depression scores as assessed by TCM symptom rating scale;Quality of life scores as assessed by FACT-B;Cholic acid metabolism in peripheral blood;T lymphocyte subsets in peripheral blood;