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Clinical efficacy evaluation of Huayu Pills and Yingxindan in the treatment of patients with stable angina pectoris a randomized single-blind parallel-controlled non-inferiority clinical study

Clinical efficacy evaluation of Huayu Pills and Yingxindan in the treatment of patients with stable angina pectoris - a randomized single-blind parallel-controlled non-inferiority clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000274
Enrollment
Unknown
Registered
2025-02-15
Start date
2023-04-11
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

stable angina pectoris

Interventions

experimental group:Administer Huayu pill
experimental group:Administer Yingxin Dan.
control group:Administer Shexiang Baoxin Pill

Sponsors

Dongzhimen Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18 and 85 years old (including the boundary values) regardless of gender; (2) Meeting the western medicine diagnostic criteria for stable angina pectoris of coronary heart disease; (3) Having a history of stable angina pectoris for no less than 2 months; (4) Having an average of =1 angina pectoris attack per week in the 1 month before enrollment; (5) The angina pectoris is graded as II - III according to the Canadian Cardiovascular Society (CCS) angina grading system; (6) Signing the informed consent form

Exclusion criteria

Exclusion criteria: (1) Hypertension that cannot be controlled after drug treatment (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg); (2) Increased risk of bleeding: history of previous hemorrhagic stroke; intracranial aneurysm; trauma or major surgery (including bypass surgery) within the past month; currently suffering from active bleeding diseases etc.; (3) Patients with a history of peptic ulcer or massive gastrointestinal bleeding; (4) Patients with severe organic heart disease such as those with left ventricular ejection fraction (LVEF) < 35% or those classified as New York Heart Association (NYHA)/Killip class IV in cardiac function; (5) Patients with a history of malignant arrhythmia (arrhythmia with hemodynamic impact requiring drug treatment electrical cardioversion or cardiopulmonary resuscitation) congenital heart disease or malignant tumor within the past year and those whom the investigators consider unfit to participate in the trial; (6) Severe hepatic or renal insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3× upper limit of normal (ULN) or total bilirubin (TBIL) = 2× ULN; or creatinine clearance rate (Ccr < 30 ml/min); (7) Pregnant women (pregnancy is defined as a positive blood pregnancy test) or lactating women; (8) Those who have donated blood or had significant blood loss (= 400 ml) within the past three months; (9) Those with a history of alcoholism [i.e. men who consume = 28 standard units of alcohol per week and women who consume = 21 standard units of alcohol per week (1 standard unit contains 14 g of alcohol such as 360 mL of beer 25 mL of spirits with 40% alcohol content or 150 mL of wine)]; or those who have been regular drinkers (i.e. consuming more than 14 standard units of alcohol per week) within the six months before screening; (10) Those with a history of drug abuse or drug dependence within the past year before screening; (11) Those who have participated in other clinical trials and taken investigational drugs within the past three months; (12) Those who are allergic to or intolerant of aspirin or P2Y12 receptor inhibitors; (13) Those who are allergic to the components of the investigational drug; (14) Other situations where the investigators consider it inappropriate for the patient to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Seattle Angina Questionnaire;

Secondary

MeasureTime frame
The incidence of major adverse cardiovascular events;The usage of nitroglycerin and the discontinuation/reduction rate;Scoring of the Four Diagnostic Methods Information in Traditional Chinese Medicine;The average number of angina attacks per week;

Countries

china

Contacts

Public Contactlijing zhang

Dongzhimen Hospital Beijing University of Chinese Medicine

dzmyyccu@163.com010-84013181

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 19, 2026