Skip to content

A randomized controlled study on the intervention of Shen Qi Yang Xin Formula in stable coronary heart disease

A randomized controlled study on the intervention of Shen Qi Yang Xin Formula in stable coronary heart disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000215
Enrollment
Unknown
Registered
2024-08-12
Start date
2024-08-20
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stable coronary heart disease

Interventions

Control group:
Experimental group:Shen Qi Yang Xin Granule

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion 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

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. (11) Patients whose coronary CTA images are unavailable or of poor quality for plaque characterization or hydrodynamic analysis.

Design outcomes

Primary

MeasureTime frame
FAI;CT-FFR;Imaging features of high-risk plaques;Chinese Medicine Symptom Score;WSS;

Secondary

MeasureTime frame
cardiac ultrasound;MACE;12-lead electrocardiogram;Seattle Angina Scale Score;

Countries

china

Contacts

Public ContactDawu Zhang

Xiyuan Hospital, China Academy of Chinese Medical Sciences

dawu4403@sina.com+86 188 1092 2297

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 9, 2026