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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of QishenYiqiDiwan in Improving Vascular Endothelial Function in Patients with Coronary Heart Disease

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of QishenYiqiDiwan in Improving Vascular Endothelial Function in Patients with Coronary Heart Disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100932
Enrollment
Unknown
Registered
2025-04-17
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Coronary atherosclerotic heart disease

Interventions

experimental group:Qishen Yiqi Drop Pill 0.52 g/time, 3 times a day
control group:placebo 0.52 g/time, 3 times a day

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: 40 years old <= age <=75 years old; 2: confirmed coronary artery disease by coronary CTA or coronary angiography (coronary CAD-RADS grade 2 or above or the degree of stenosis in the most severe site of coronary angiography =50%), without acute coronary syndrome related symptoms or underwent revascularization within 1 year; 3: Abnormal vascular endothelial function (FMD<=7%); 4: normal or mildly abnormal liver and kidney function (< 2 times the upper limit of normal); 5: no blood system disease; 6: meet the following criteria: a. Self-care or basic self-care; b. good nutritional status; c. Basically positive cognitive function Often; d. Optimistic, positive and self-satisfied; e. Have certain health literacy and maintain a good lifestyle; f. Active participation in family and social activities; g. Good social adaptability; 7: Informed consent was obtained. Exclusion criteria.

Exclusion criteria

Exclusion criteria: 1: There are contraindications to the use of Qishen Yiqi dropping pills: those who have allergic reactions to this product are contraindicated; 2: taking medications such as nitrates or alprostadil for unstable angina or other reasons; 3: diabetic patients; 4: previous major cardiovascular events, including massive myocardial infarction, stroke, repeated revascularization, or repeated hospitalization for angina; 5: patients with heart failure; 6: malignant tumor patients; 7: Unable to cooperate with treatment and follow-up; 8: Participating in other clinical trials; 9: pregnant or lactating women; 10: Persons that the investigators believed should not be included.

Design outcomes

Primary

MeasureTime frame
Flow-Mediated Dilation;

Secondary

MeasureTime frame
Reactive Hyperemia Index;Carotid intimal medial thickness, IMT;Cardiovascular events;Blood pressure;Cyclic molecular markers;brachial ankle pulse wave velocity;Lymphocyte Subsets;

Countries

China

Contacts

Public ContactCuntai Zhang

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

ctzhang0425@163.com+86 159 2766 8408

Outcome results

None listed

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