Yiyang Huoluo Decoction for coronary heart disease with atherosclerosis in older adults

Clinical and Basic Research on the Treatment of Senile Atherosclerosis and Coronary Heart Disease With Yiyang Huoluo Decoction

This study will test whether adding the Yiyang Huoluo herbal decoction to standard heart care helps people aged 50–75 with coronary heart disease and atherosclerosis.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 50 Years to 75 Years
• Sex: All
• Sponsor: Hangzhou City University (Academic / other)
• Locations: 1 site (Huzhou, Zhejiang)
• Trial ID: NCT07493603 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 interventional study compares standard Western medical therapy alone versus standard therapy plus Yiyang Huoluo Decoction in older adults with stable angina and coronary atherosclerosis. Participants aged 50–75 with CCS class I–III angina and prior drug-eluting stent implantation will be enrolled and assigned to one of two treatment groups. Researchers will monitor safety alongside clinical outcomes such as angina symptoms, cardiac-related measures, and laboratory or cellular markers of vascular health and repair. The trial aims to characterize tolerability when combined with routine heart medications and to provide preliminary signals of benefit.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50–75 with stable angina (CCS I–III), coronary atherosclerosis, prior drug-eluting stent implantation, and the specified traditional Chinese medicine pattern who meet other health and consent requirements.

Not a fit: People with acute coronary syndrome, those outside the 50–75 age range, those who do not match the trial's TCM diagnostic pattern, or those with serious uncontrolled comorbidities are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this herbal add-on could reduce angina symptoms and support blood vessel repair when used with standard heart medications in older adults.

How similar studies have performed: Some small trials of Chinese herbal formulas as adjuncts to conventional care have reported symptomatic or biomarker improvements, but high-quality large randomized evidence in coronary disease remains limited.

Eligibility criteria

Inclusion Criteria:

All of the following conditions must be met simultaneously for enrollment:

* ① Meet the diagnostic criteria for stable angina pectoris;
* ② Classified as Grade I to III according to the Canadian Cardiovascular Society (CCS) Angina Grading Scale;
* ③ Meet the diagnostic criteria for chest discomfort syndrome due to yang qi deficiency and decline (a traditional Chinese medicine pattern differentiation);
* ④ Aged between 50 and 75 years old;
* ⑤ Received drug-eluting stent implantation due to severe vascular stenosis (single artery ≥75%， or LM ≥50%) detected by coronary angiography;
* ⑥ Able to actively comply with medical instructions and voluntarily sign the written informed consent form.

Exclusion Criteria:

Participants will be excluded if they meet any of the following conditions:

* ① Diagnosed with acute coronary syndrome (including acute ST-segment elevation myocardial infarction, acute non-ST-segment elevation myocardial infarction, and unstable angina pectoris) after relevant examinations;
* ② Suffer from chest pain caused by non-cardiac diseases other than stable angina pectoris; or have complicated severe hypertension (systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 110mmHg), severe cardiopulmonary insufficiency, or malignant tumor;
* ③ Have severe endocrine, hematological or rheumatic immune system diseases, severe hepatic and renal dysfunction, active gastrointestinal bleeding, or mental illness;
* ④ Have an allergic constitution or a history of allergic reactions to traditional Chinese medicine;
* ⑤ Have incomplete major baseline data that may affect the trial results, or have participated in other clinical trials recently.

Where this trial is running

Huzhou, Zhejiang

• People's Hospital of Anji — Huzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Liang Xia, Doctor

Conditions Coronary Heart Disease; Coronary Artery Disease; Atheroscleroses