Health TrialsbyHealthPanel

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

ConditionsCoronary Heart DiseaseCoronary Artery DiseaseAtheroscleroses
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50-75
SponsorXia Liang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: YH groupExperimental treatment 2 interventions
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

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.)

Time frame
baseline, 12 weeks, and 36 weeks of treatment
2

CCS angina pectoris grade

Time frame
baseline, 12 weeks, 36 weeks of treatment
3

Incidence of in-stent restenosis

detected by coronary angiography

Time frame
36-week of treatment

Secondary outcomes

1

Changes in carotid intima-media thickness (IMT)

detected by carotid ultrasound

Time frame
baseline, 12 weeks, and 36 weeks of treatment
2

Total incidence of adverse events (AEs)

Time frame
during the 36-week treatment period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xia Liang

Lead sponsor

Hangzhou City University

Sponsor institution

Source ClinicalTrials.gov
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