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A multicenter, randomized, double-blind, multi-dose, parallel-controlled, phase II exploratory study on the treatment of chronic stable angina pectoris (sputum stasis and blockage) with Gua-Xie-Xin-Tong dropping pills

A multicenter, randomized, double-blind, multi-dose, parallel-controlled, phase II exploratory study on the treatment of chronic stable angina pectoris (sputum stasis and blockage) with Gua-Xie-Xin-Tong dropping pills

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003451
Enrollment
Unknown
Registered
2020-07-02
Start date
2020-06-29
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Coronary Heart Disease

Interventions

Sponsors

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) According to the diagnostic criteria of stable exertional angina pectoris, CCS grade I and II; (2) Angina pectoris occurred more than 3 times a week on average one month before enrollment; (3) The history of stable angina pectoris was more than 3 months; (4) Angina pectoris symptoms, and at least one of the following evidence for the diagnosis of coronary heart disease: A. history of myocardial infarction in the past; B. had received coronary revascularization, including PCI and CABG; C. coronary angiography or coronary CTA examination showed at least one coronary artery stenosis and lumen stenosis >= 50%, or myocardial ischemia of coronary heart disease was diagnosed by static or dynamic radionuclide myocardial scanning; D. ischemic ECG changes: during angina pectoris attack, ST segment measured from 0.08 s after J point in the lead with R wave dominant in ECG showed horizontal or downward oblique depression, with depression >= 1.0 mm or ST segment elevation >= 1.0 mm compared with P-R segment. (5) TCM syndrome differentiation belongs to the syndrome of phlegm and blood stasis obstructing collaterals, with more than 1 main symptom and more than 2 secondary symptoms; (6) The age was 30-65 years old, with no gender limit; (7) Informed consent, voluntary subjects. The process of obtaining informed consent is in accordance with GCP.

Exclusion criteria

Exclusion criteria: (1) The left main artery disease was not treated effectively; (2) Clinical significance of valve disease, congenital heart disease, pulmonary embolism, chronic obstructive pulmonary disease, bronchial asthma, stroke, dissecting aneurysm, sick sinus syndrome, hypertrophic obstructive cardiomyopathy, acute myocarditis / pericarditis, congenital long QT syndrome; (3) In patients with congestive heart failure NYHA grade III or IV or acute pulmonary edema, left ventricular ejection fraction (LVEF) was less than 50% on echocardiography; (4) Patients with non sinus rhythm, or with arrhythmia (such as degree II, III atrioventricular block, bundle branch block, preexcitation syndrome, atrial fibrillation, atrial flutter, sick sinus syndrome, etc.), or with pacemaker or cardioverter; (5) CABG or PCI within three months; (6) Severe and uncontrolled hypertension (>=160 / 100mmhg), hypotension ( 1.5 times of the upper limit of normal value), kidney (SCR > upper limit of normal value), hematopoietic system and other serious primary diseases, mental patients; (9) Pregnant or lactating women or those who are ready for pregnancy recently. (10) People with disabilities prescribed by law (blindness, deafness, dumb, mental retardation, etc.). (11) Those who are allergic to the components of this preparation. (12) Patients who are participating in clinical trials of other drugs within 4 weeks. Suspected or confirmed history of alcohol and drug abuse, or other situations that reduce the possibility of enrollment or complicate the enrollment according to the judgment of the researcher, such as frequent changes in the working environment, which may easily lead to loss of follow-up.

Design outcomes

Primary

MeasureTime frame
Weekly nitroglycerin consumption;Seattle Angina scale score;Number of angina attacks per week;VAS score of pain degree;Duration of angina attack;Electrocardiogram treadmill exercise test;Symptoms of traditional Chinese Medicine;24-hour Holter myocardial ischemic load;Severity classification of angina pectoris;Resting and drug loading myocardial radionuclide imaging;

Countries

China

Contacts

Public ContactJianpeng Du
13811518062@163.com+86 13811518062

Outcome results

None listed

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