Cardiovascular and cerebrovascular diseases
Conditions
Interventions
Research group:Starting from the day after enrollment, administer 0.4g of Xiaoshuan enteric coated capsules orally three times a day, half an hour before meals, for a continuous period of 30 days
Control group:On the day after enrollment, placebo was administered orally three times a day, half an hour before meals, for a continuous period of 30 days
Sponsors
First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) 18 = Age = 80; 2) 14 days = 90 days for patients with clear myocardial infarction or coronary heart disease after PCI or cerebral infarction; 3) Having two or more Qi deficiency symptoms (dull tongue texture, white and greasy tongue coating, fatigue and laziness, self sweating, palpitations, white face, constipation, and deep and thin pulse) 4) Fatigue Severity Scale (FSS) = 36. 5) The research participants or legal guardians agree to receive the drug treatment methods formulated in the research protocol, participate in the evaluation on time, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with consciousness disorders; 2) Hemorrhagic stroke or mixed stroke; 3) Known brain tumors/metastases and tumors in other parts of the body, or other chronic comorbidities that may affect the lives of study participants or limit the research process; 4) Research participants with major illnesses include but are not limited to: severe kidney disease requiring hemodialysis or peritoneal dialysis; Or advanced liver disease, such as cirrhosis; Or severe congestive heart failure (NYHA grades 3 and 4); Or severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease (COPD) and a history of lung resection; Or patients with severe hematological disorders such as coagulation disorders, systemic bleeding tendency, and thrombocytopenia; 5) Known history of Alzheimer's disease or other dementia, Parkinson's disease, motor neuron disease, epilepsy, or any other neurological disorder that researchers believe may affect their ability to participate in trials or confuse research evaluations; History of cerebral hemorrhage or subarachnoid hemorrhage in the past 12 months; 6) Known severe mental illness patients; 7) Patients with immune dysfunction, known autoimmune diseases, or undergoing immunosuppressive therapy; 8) History of alcohol or drug abuse within the past 6 months; 9) Individuals with severe allergy tendencies or allergic reactions to any component of the enteric coated capsules of Xiaoshuan; 10) Individuals who have undergone major surgeries (such as tumor resection, thoracotomy, non-invasive cardiac surgery, abdominal surgery, intracranial surgery, or normal surgery lasting more than 3 hours) within the first 30 days; 11) Uncontrollable severe hypertension (systolic blood pressure = 180mmHg or diastolic blood pressure = 110mmHg), diabetes (blood sugar = 50 mg/dL or = 400 mg/dL); 12) In laboratory tests, the following results were obtained: alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>2 times the upper limit of normal (ULN); Or serum creatinine>2 times ULN; 13) Human immunodeficiency virus (HIV), syphilis, hepatitis B, hepatitis C and other infectious diseases were found during blood examination; 14) Within one week, there are infected individuals (including respiratory diseases such as pneumonia, urinary system infections, etc.); 15) Patients who are pregnant, breastfeeding, or have the possibility or plan of pregnancy; 16) The researchers determined that the participants were not suitable for this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90th day FAI fatigue scale score;90th day Qi Deficiency Scale Score;90th day Blood Stasis Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90 day ASCVD event recurrence rate;30th day FAI fatigue scale score;30th day Qi Deficiency Scale Score;30th day Blood Stasis Scale Score; | — |
Countries
China
Contacts
Public ContactYong Liu
First affiliated hospital of Dalian Medical University
Outcome results
None listed