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NCT Number: NCT07493603

A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease

The goal of this clinical trial is to learn if Yiyang Huoluo Decoction (a custom Chinese herbal medicine) works safely and effectively to treat coronary heart disease with atherosclerosis in older adults. It also aims to find out how this herbal treatment may affect blood vessel health and repair at a cellular level.

The main questions it aims to answer are:

* Does adding Yiyang Huoluo Decoction to standard Western medical care improve symptoms and heart-related health in older adults with coronary heart disease and atherosclerosis? * Is Yiyang Huoluo Decoction safe for older adults to take alongside their regular heart medications? * How does this herbal treatment affect the damaged blood vessels in study participants?

Researchers will compare two groups of participants to see if the combined treatment works better than standard care alone.

Who can take part: Older adults diagnosed with coronary heart disease and atherosclerosis who meet the study's health and eligibility rules.

What participants will do:

* Be split randomly into two groups of 15 people each: one group gets standard Western heart medicine only, and the other gets standard Western heart medicine plus Yiyang Huoluo Decoction (herbal granules) * Complete the 12-week decoction treatment plan as directed by the research team * Attend scheduled study visits for health checks, blood tests, heart and blood vessel scans (such as carotid ultrasound and coronary CTA), and symptom reviews * Provide two small blood samples for research testing (samples will be destroyed after study testing is finished) * Report any side effects, discomfort, or changes in health to the research team right away

All personal health information collected for this study will be kept private and confidential. Participation is completely voluntary, and participants may quit the study at any time for any reason without losing access to regular medical care.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

People's Hospital of Anji

Huzhou, Zhejiang, China

Location status: Recruiting

Location contact

Xiaoli Lu

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yiyang Huoluo Decoction

Drug

The principal constituents of this decoction include Rehmanniae Radix (dried rehmannia root), Dioscoreae Rhizoma (Chinese yam rhizome), Cornus Officinalis Fructus (Asiatic dogwood fruit), Alismatis Rhizoma (water plantain rhizome), Poria Cocos (Indian bread), Moutan Cortex (moutan bark), Cinnamomi Ramulus (cinnamon twig), Astragali Radix (milk vetch root), Angelicae Sinensis Radix (Chinese angelica root), Pheretima (earthworm), Persicae Semen (peach seed), and Carthami Flos (safflower)

Conventional Western medicine treatment

Drug

including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents

Primary outcomes

  1. TCM syndrome scores for chest discomfort due to yang qi deficiency and decline

    Time frame: baseline, 12 weeks, and 36 weeks of treatment

    TCM Syndrome Rating Scale for Chest Discomfort (Yang Qi Deficiency and Decline) (It includes 8 main symptoms, each scored 0-3, with a total score of 0-24. Higher scores represent more severe syndromes.)

  2. CCS angina pectoris grade

    Time frame: baseline, 12 weeks, 36 weeks of treatment

  3. Incidence of in-stent restenosis

    Time frame: 36-week of treatment

    detected by coronary angiography

Secondary outcomes

  1. Changes in carotid intima-media thickness (IMT)

    Time frame: baseline, 12 weeks, and 36 weeks of treatment

    detected by carotid ultrasound

  2. Total incidence of adverse events (AEs)

    Time frame: during the 36-week treatment period

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Xia, Doctor

CONTACT

[email protected]

86-15057172609

Sponsors and collaborators

Lead sponsor

Xia Liang

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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