Coronary Heart Disease
Conditions
Interventions
control group:Yuxintong Capsule placebo + conventional treatment
Test group:Yuxintong Capsule + conventional treatment
Sponsors
The First Affiliated Hospital of Henan University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
35 Years to 79 Years
Inclusion criteria
Inclusion criteria: (1) 35 years = age = 79 years; (2) Patients who meet the diagnostic criteria for coronary artery disease, have undergone percutaneous coronary intervention (PCI) surgery more than 7 days but less than 365 days ago, have residual lesions in the main vessels and branches <50%, and are judged by a cardiovascular specialist to not require elective coronary revascularization surgery (PCI, CABG); (3) Clinical symptoms: Presence of chest pain, chest tightness, shortness of breath, palpitations, fatigue, dyspnea, or decreased exercise tolerance, with a Visual Analog Scale (VAS) score =4 points in the Short Form McGill Pain Questionnaire (SF-MPQ); (4) Generalized Anxiety Disorder 7-item scale (GAD-7) =15 points or Patient Health Questionnaire 9-item scale (PHQ-9) =15 points; (5) Chinese medicine diagnosis: Qi deficiency and blood stasis syndrome; (6) Voluntarily participating in this study and having signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Chest pain caused by confirmed conditions or as determined by the investigator including aortic dissection pulmonary embolism acute coronary syndrome atypical angina (such as upper abdominal pain neck pain mandibular pain etc.) osteoporotic pain gastroesophageal disorders trauma or localized soft tissue disorders dermatological diseases etc.; (2) Presence of pulmonary heart disease severe valvular heart disease rheumatic heart disease; severe heart failure uncontrolled acute pulmonary edema due to left heart failure severe cardiogenic shock malignant arrhythmias poorly controlled by medication; uncontrolled hypertension (systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg); history of prolonged cardiopulmonary resuscitation (>20 minutes); (3) Presence of confirmed mechanical complications including ventricular septal rupture papillary muscle rupture or ongoing/already ruptured left ventricular free wall; (4) Concomitant hyperthyroidism pheochromocytoma or other severe endocrine or metabolic disorders; (5) Severe hepatic or renal impairment (ALT or AST > 2 times the upper limit of normal severe renal dysfunction defined as serum creatinine [Cr] = 3 mg/dL or eGFR = 60 ml/min·1.73m² or regular dialysis) hematologic diseases acute infectious diseases autoimmune disorders malignancies or other serious comorbidities; (6) History of bleeding from the brain gastrointestinal tract respiratory tract urinary tract or other organs within the past month; known bleeding tendency or severe disorders of hemostasis and coagulation; (7) Severe anxiety or depression; (8) Use of traditional Chinese medicine with similar therapeutic effects (including decoctions proprietary Chinese medicines or injectable formulations) within 7 days prior to enrollment; (9) Known allergy or hypersensitivity to the investigational drug or any of its excipients; (10) Women of childbearing age who are pregnant or lactating have plans to conceive within six months test positive on a pregnancy test or are unable to use effective contraception during the study period; (11) Participation in other clinical trials within the past 3 months; (12) Inability to comply with the study schedule for assessments and follow-up or deemed unsuitable for participation by the investigator based on clinical judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Simplified McGill Pain Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Seattle Angina Questionnaire ;The Efficacy Assessment Scale for Qi Deficiency and Blood Stasis Syndrome;Patient Health Questionnaire-9 items;Generalized anxiety disorder-7;Somatic Symptom Scale (SSS) score; | — |
Countries
China
Contacts
Public ContactLi Ming
The First Affiliated Hospital of Henan University of Chinese Medicine
Outcome results
None listed