Qiaoning 2019.

Study name	Effect of guanxindanshen dropping pills on quality of life and cardiovascular prognosis of patients with depression or anxiety after PCI for coronary heart disease
Methods	RCT design: 2‐arm parallel‐group trial Total N randomised: 200 Length of follow‐up: not specified Analysis: not specified
Participants	Location: China Number of study centres and setting: 6 hospital recruitment sites: Xiyuan Hospital, CACMS (Beijing); Shanghai Tongji Hospital (Shanghai); Fuwai Hospital, CAMS & PUMC (Beijing); Guangdong Provincial People's Hospital (Guangzhou); Beijing First Hospital of Integrated Chinese and Western Medicine (Beijing); The Affiliated Hospital of Changchun University of TCM (Changchun) CAD criteria: diagnostic criteria of CHD (not specified) and complete PCI procedure Depression criteria: PHQ‐9 score 5 to 14 or Generalized Anxiety Disorder‐7 Scale score 5 to 14, or both Other entry criteria: voluntary participation and informed consent, age 18 to 75 years, able to co‐operate with examination and treatment Exclusion criteria: Quote: "wicked liquid condition" Unalleviated angina attack or NYHA cardiac function grade IV Electrolyte disorder, acid‐base imbalance Complicated with pulmonary, liver, kidney, haematopoietic system, immune system, and other serious primary diseases and dysfunction Organic mental disorders, depression caused by other mental disorders such as schizophrenia or somatic diseases, etc. Bipolar disorder, rapid circulatory seizures History of epilepsy Alcohol or drug abuse within 1 year Other antidepressants and antianxiety drugs used within 4 weeks before the trial Pregnant or lactating women or planned pregnancies Those who have participated in clinical trials of other drugs within 3 months Researcher does not consider it appropriate for patient to participate in clinical trials Suicide‐prone patients
Interventions	Intervention: guanxin danshen dropping pills, therapeutic dose or intake not specified Control: placebo, unclear
Outcomes	Primary: depression measured by the PHQ‐9, major adverse cardiac events, angina measured by the Seattle Angina Questionnaire Secondary: quality of life measured with the 12‐Item Short Form Health Survey, blood pressure, vital signs, microcirculation and inflammatory‐related indicators, adverse events
Starting date	1 March 2017
Contact information	Yang Qiaoning Xiyuan Hospital, CACMS 1 Xiyuan Caochang, Haidian District, Beijing, China T: +86 15101072110 E: 15101072110@126.com
Notes