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Prospective, randomized, double-blind, placebo-controlled clinical study of Yuekang Huoxin Pill (concentrated pill) intervening in the prognosis of patients with coronary heart disease after DCB with qi deficiency and blood stasis syndrome

Clinical evaluation and mechanism research on promoting blood circulation and detoxification to prevent restenosis after PCI

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051859
Enrollment
Unknown
Registered
2021-10-07
Start date
2022-03-04
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

coronary heart disease

Interventions

Experimental group:Yuekang Huoxin Pills (concentrated pills) 2 pills at a time, 3 times a day
Control group:Yuekang Huoxin Pills (concentrated pills) simulant 2 pills at a time, 3 times a day

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. Patients who meet the diagnostic criteria of Western medicine for coronary heart disease, elective patients within two weeks after DCB surgery, including patients with primary large-vessel lesions or in-stent restenosis; 3.Meet the TCM criteria for syndrome differentiation of Qi deficiency and blood stasis (total score >= 8 points, and secondary symptoms >= 4 points); 4. The patients voluntarily participated in the trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe arrhythmia, severe cardiopulmonary insufficiency and poorly controlled hypertension; 2. Patients with serious primary diseases such as severe liver and kidney damage, hematopoietic system, and mental illness; 3. Patients with heart valve disease, cardiomyopathy, congenital heart disease, aortic dissection or aortic aneurysm that need to be corrected by surgery or interventional therapy; 4. Patients with acute myocardial infarction, stroke and transient ischemic attack within 6 months; 5. Pregnant, planning pregnancy or lactating patients; 6. Allergic constitution and those who are allergic to known components of the research drug; 7. Those who are participating in other clinical trials or have participated in other drug clinical trials within one month; 8. Those who are judged by the investigator to be unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
quantitative flow fraction (QFR) values at 12-month postoperative follow-up;

Secondary

MeasureTime frame
quantitative flow fraction (QFR) change values;late lume loss;binary restenosis;diameter stenosis;incidence of revascularization;incidence of cardiovascular composite endpoints;incidence of main adverse cardiac events composite endpoints;TCM syndrome scale;

Countries

China

Contacts

Public ContactMa Lihong

Fuwai Hospital, Chinese Academy of Medical Sciences

mlh8168@163.com+86 186 0190 2828

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026