Geng 2018.
| Study name | Effect of guanxin danshen dropping pill on clinical anxiety, depression, heart rate variability and cardiovascular prognosis in patients with coronary heart disease after PCI combined with anxiety or depression |
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 100 Length of follow‐up: no follow‐up Analysis: not specified |
| Participants | Location: China Number of study centres and setting: Guangdong General Hospital CAD criteria: CHD, any stable angina pectoris, unstable angina pectoris, non‐ST‐elevation myocardial infarction, acute ST‐segment elevation myocardial infarction, PCI patients (completed or required) Depression criteria: patients who scored between 5 to 14 points on the PHQ‐9, or score of between 5 and 14 points on the Generalized Anxiety Disorder‐7 Other entry criteria: voluntarily participate in the trial, signed informed consent and ability to understand and voluntarily sign informed consent, aged between 18 and 75 years, can co‐operate with the treatment Exclusion criteria: cachexia state; or combined lung, liver, kidney, haematopoietic system, immune system, and other serious primary disease and dysfunction, angina pectoris not relieved or NYHA cardiac function grade IV, recurrent anxiety, depression patients, electrolyte imbalance acid‐base imbalance, history of epilepsy, or patients with organic mental disorders, other mental illness such as: bipolar affective disorder, schizophrenia, and other patients, alcohol and drug abuse and addiction within 1 year, use of other antidepressant and anxiolytic drugs within 4 weeks before assessment, pregnant or lactating women, or planned pregnancy, had previous coronary revascularisation, participated in other drug clinical trials within 3 months, researchers believe that patient is not suitable for clinical trials, patients with cognitive impairment, patients with suicidal tendencies |
| Interventions | Guanxin danshen drop pills. No further information available. Duration of treatment: not specified |
| Outcomes | Symptoms of anxiety and depression Heart rate variability during cardiopulmonary exercise Major adverse cardiovascular events (MACE) |
| Starting date | 1 August 2017 |
| Contact information | Qingshan Geng 106 Second Zhongshan Road, Guangzhou, Guangdong, China T: +86 13922205818 E: mahuannovel@163.com |
| Notes | http://www.chictr.org.cn/showproj.aspx?proj=20507 |