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Clinical study on Xinpi Tongzhi Formula in improving the prognosis of Coronary small Vascular lesions with Drug Balloon dilatation

Clinical study on Xinpi Tongzhi Formula in improving the prognosis of Coronary small Vascular lesions with Drug Balloon dilatation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085963
Enrollment
Unknown
Registered
2024-06-21
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

coronary artery disease

Interventions

Treatment group:On the basis of routine treatment of western medicine, take Xinpi Tongzhi prescription twice a day, 1 bag each time, and take it with warm boiled water.
Control group:On the basis of routine treatment of western medicine, take the placebo of Xinpi Tongzhi prescription twice a day, 1 bag each time, and take warm boiled water.

Sponsors

Xiyuan Hospital of Chinese Academy of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) 18 years old = age = 75 years old, regardless of gender. (2) Coronary angiography showed coronary artery small vessel lesions (lumen diameter = 2.75mm), stenosis = 70%. (3) Drug balloon dilatation within 1 year. (4) in accordance with the diagnostic criteria of heart-spleen-qi deficiency and blood stasis syndrome in traditional Chinese medicine. (5) those who sign the informed consent form will be tested voluntarily.

Exclusion criteria

Exclusion criteria: (1) it is difficult to control decompensated heart failure, acute myocarditis, pericardial disease, valvular heart disease, primary cardiomyopathy and severe left ventricular hypertrophy. (2) recurrent patients with malignant arrhythmias (ventricular tachycardia, supraventricular arrhythmias affecting hemodynamics, atrioventricular block above ? °). (3) complicated with malignant hypertension (systolic blood pressure = 200mmHg, or diastolic blood pressure = 120mmHg) or severe hypotension (diastolic blood pressure < 90mmHg). (4) patients with acute cerebrovascular disease, severe primary diseases such as lung, liver, kidney, hematopoietic system, malignant tumor, mental illness and severe neurosis. (5) pregnant or preparing pregnant women, lactating women and those who are allergic to known ingredients of research drugs. (6) those who have participated or are participating in other clinical trials in the past three months. (7) patients who need continuous mechanical auxiliary therapy after successful interventional therapy.

Design outcomes

Primary

MeasureTime frame
Peak VO2, METs;Primary end point index (all-cause death, stroke, non-fatal myocardial infarction, emergency revascularization);Secondary end point index (due to rehospitalization of coronary heart disease, cardiac insufficiency, malignant arrhythmia and other thrombotic complications);

Secondary

MeasureTime frame
Seattle angina pectoris scale;Score of blood stasis syndrome of coronary heart disease;Glycosylated hemoglobin;Low density lipoprotein cholesterol;Inflammatory index;

Countries

China

Contacts

Public ContactJianpeng Du

Xiyuan Hospital, China Academy of Chinese Medical Sciences

13811518062@163.com+86 138 1151 8062

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026