ITMCTR2024000215
Not yet recruiting
Early Phase 1
A randomized controlled study on the intervention of Shen Qi Yang Xin Formula in stable coronary heart disease
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Xiyuan Hospital, China Academy of Chinese Medical Sciences
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Meet the diagnostic criteria for stable coronary artery disease, and Coronary CTA or coronary angiography shows a 50%\-70% narrowing of the lumen diameter of at least one major branch;
- •(2\) Coronary CTA within the past month shows CT\-FFR \>0\.8;
- •(3\) Meet the diagnostic criteria of Qi deficiency and blood stasis;
- •(4\) Age 30\-75 years old, no gender restriction;
- •(5\) Volunteer to be tested and sign an informed consent form.
Exclusion Criteria
- •(1\) Acute myocardial infarction or coronary artery revascularization treatment within the last 30 days.
- •(2\) Those who have one of the following diseases: a. Hypertension and still high blood pressure after treatment with antihypertensive drugs (systolic blood pressure \=160mmHg, diastolic blood pressure \=100mmHg); b. Severe malignant arrhythmia, pulmonary heart disease, rheumatoid artery disease, myocarditis, cardiomyopathy, aortic coarctation, pulmonary embolism and other serious diseases.
- •(3\) Those with symptoms of chest pain associated with diseases such as hyperthyroidism, ervical spondylosis, bile\-cardiac syndrome, esophageal hiatal hernia, neurosis, and menopausal syndrome.
- •(4\) Those at risk of severe bleeding.
- •(5\) Those with serum ghrelin or serum creatinine \>3 times the upper limit of normal reference value.
- •(6\) Those with severe hematologic diseases and malignant tumors.
- •(7\) Those with one of the following contraindications to coronary CTA: a. Previous history of severe allergic reaction to contrast media; b. Patients who are unable to cooperate with scanning and breath\-holding; c. Pregnant women, lactating women, or women of childbearing age with childbearing requirements; d. Clinical signs of life are unstable (e.g., acute myocardial infarction, decompensated heart failure, severe hypotension, etc.); e. Severe renal insufficiency.
- •(8\) Persons who are mentally ill or have cognitive dysfunction.
- •(9\) Hypersensitivity to the test drug.
- •(10\) Participation in other clinical trials within the last 1 month, or oral administration of blood\-activating and blood\-stasis\-relieving herbal preparations.
Outcomes
Primary Outcomes
Not specified
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