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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:
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH group | Experimental | receive 12-week YH decoction treatment with 36-week conventional western medicine treatment: including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents |
|
| Control Group | Other | only receive 36-week conventional western medicine treatment: including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time 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 |
| Measure | Description | Time 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 |
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Inclusion Criteria:
All of the following conditions must be met simultaneously for enrollment:
Exclusion Criteria:
Participants will be excluded if they meet any of the following conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Xia, Doctor | Contact | 86-15057172609 | 407928215@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Anji | Recruiting | Huzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| conventional western medicine treatment | Drug | including antiplatelet drugs, statins, beta-blockers, and ACEI/ARB agents |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |