mild to moderate depression of Breast cancer patients
Conditions
Interventions
A:Sinisan-Washout period-Placebo
B:Placebo-Washout period-Sinisan
Sponsors
Zhiyu Wang
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression scores as assessed by HAMD-24; | — |
Secondary
| Measure | Time frame |
|---|---|
| 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; | — |
Countries
China
Contacts
Public ContactZhiyu Wang
Outcome results
None listed