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

March 23, 2026 updated by: Xia Liang

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Huzhou, Zhejiang, China
        • Recruiting
        • People's Hospital of Anji
        • Contact:
          • Xiaoli Lu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YH group
receive 12-week YH decoction treatment with 36-week conventional western medicine treatment: including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents
Drug: Yiyang Huoluo Decoction
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)
Drug: conventional western medicine treatment
including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents
Other: Control Group
only receive 36-week conventional western medicine treatment: including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents
Drug: conventional western medicine treatment
including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
baseline, 12 weeks, and 36 weeks of treatment
CCS angina pectoris grade
Time Frame: baseline, 12 weeks, 36 weeks of treatment
baseline, 12 weeks, 36 weeks of treatment
Incidence of in-stent restenosis
Time Frame: 36-week of treatment
detected by coronary angiography
36-week of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in carotid intima-media thickness (IMT)
Time Frame: baseline, 12 weeks, and 36 weeks of treatment
detected by carotid ultrasound
baseline, 12 weeks, and 36 weeks of treatment
Total incidence of adverse events (AEs)
Time Frame: during the 36-week treatment period
during the 36-week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xia Liang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2026

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20250050

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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