A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Yiyang Huoluo Decoction, conventional western medicine treatment.
- Who it may be relevant to
- Registry conditions: Coronary Heart Disease, Coronary Artery Disease, Atheroscleroses. Basic parameters: 50 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical and Basic Research on the Treatment of Senile Atherosclerosis and Coronary Heart Disease With Yiyang Huoluo Decoction
Overview
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.
Interventions
- 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
Primary outcome measures
- TCM syndrome scores for chest discomfort due to yang qi deficiency and decline [Time frame: baseline, 12 weeks, and 36 weeks of treatment]
- CCS angina pectoris grade [Time frame: baseline, 12 weeks, 36 weeks of treatment]
- Incidence of in-stent restenosis [Time frame: 36-week of treatment]
Secondary outcome measures (2)
- Changes in carotid intima-media thickness (IMT) [Time frame: baseline, 12 weeks, and 36 weeks of treatment]
- Total incidence of adverse events (AEs) [Time frame: during the 36-week treatment period]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- People's Hospital of Anji — Huzhou
Identifiers
NCT: NCT07493603 · 20250050