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Clinical Trial NCT07493603 for Coronary Heart Disease, Coronary Artery Disease, Atheroscleroses is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease Phase 1, Phase 2 30

Recruiting
Clinical Trial NCT07493603 is designed to study Treatment for Coronary Heart Disease, Coronary Artery Disease, Atheroscleroses. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 16 January 2026, with plans to enroll 30 participants. Led by Xia Liang, it is expected to complete by 30 June 2028. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary

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...
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Official Title

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

Conditions
Coronary Heart DiseaseCoronary Artery DiseaseAtheroscleroses
Other Study IDs
  • 20250050
NCT ID Number
NCT07493603
Start Date (Actual)
2026-01-16
Last Update Posted
2026-03-25
Completion Date (Estimated)
2028-06-30
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalYH group
receive 12-week YH decoction treatment with 36-week conventional western medicine treatment: including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents
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 (...Show More
conventional western medicine treatment
including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents
OtherControl Group
only receive 36-week conventional western medicine treatment: including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents
conventional western medicine treatment
including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
TCM syndrome scores for chest discomfort due to yang qi deficiency and decline
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
baseline, 12 weeks, 36 weeks of treatment
Incidence of in-stent restenosis
detected by coronary angiography
36-week of treatment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Changes in carotid intima-media thickness (IMT)
detected by carotid ultrasound
baseline, 12 weeks, and 36 weeks of treatment
Total incidence of adverse events (AEs)
during the 36-week treatment period
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
50 Years
Eligible Sexes
All

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.

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.
Xia Liang logoXia Liang
Study Responsible Party
Xia Liang, Sponsor-Investigator, professor, Hangzhou City University
Study Central Contact
Contact: Liang Xia, Doctor, 86-15057172609, [email protected]
1 Study Locations in 1 Countries

Zhejiang

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