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This is a clinical study to evaluate the effectiveness and explore the possible working mechanisms of a traditional Chinese herbal formula called Yixin Powder. The study focuses on patients with stable angina pectoris (chest pain) caused by coronary heart disease (CHD), who are diagnosed with a specific Chinese medicine pattern known as "qi deficiency and blood stasis," based on the "weak pulse at yang and wiry pulse at yin" theory.
The study hypothesizes that adding Yixin Powder to standard Western medication will be beneficial for these patients. To test this, participants diagnosed with this condition will be randomly assigned to one of two groups. One group will receive standard medication alone, while the other group will receive the same standard medication plus Yixin Powder. The effects of the treatments will be compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Pharmacological Therapy | Active Comparator | Participants in this arm receive the standard pharmacological regimen for stable angina pectoris secondary to coronary heart disease. This includes oral administration of Metoprolol succinate extended-release tablets, Aspirin enteric-coated tablets, and Atorvastatin calcium tablets. |
|
| Conventional Therapy plus Yixin Powder | Experimental | Participants in this arm receive the same standard pharmacological regimen as the Conventional Pharmacological Therapy arm. Additionally, they receive the traditional Chinese herbal formula Yixin Powder, administered orally in divided doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol Succinate Extended-Release Tablets | Drug | Metoprolol succinate extended-release tablets, 23.75 mg administered orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate based on Traditional Chinese Medicine (TCM) Syndrome Score Improvement | The comprehensive therapeutic index (N) is calculated as: [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%. Efficacy is classified as: Significant Response (N ≥ 70%), Partial Response (30% ≤ N < 70%), No Response (N < 30%), or Aggravation. The Overall Response Rate (ORR) is the proportion of participants achieving Significant or Partial Response. | Assessed before treatment initiation and after 4 weeks of treatment. |
| Response Rate based on Electrocardiogram (ECG) Improvement | Efficacy is classified as: Significant Response (ECG returns to normal/near-normal), Partial Response (marked improvement in ST segments, T waves, or conduction), No Response (no significant change), or Aggravation (worsening of ECG findings). The Overall Response Rate (ORR) is the proportion of participants achieving Significant or Partial Response. | Assessed before treatment initiation and after 4 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Seattle Angina Questionnaire (SAQ) Score | The SAQ is a disease-specific health status measure for patients with coronary artery disease. It assesses five domains: Physical Limitation, Anginal Stability, Anginal Frequency, Treatment Satisfaction, and Disease Perception. The manuscript does not specify the score range or whether a higher score indicates a better or worse outcome. | Assessed before treatment initiation and after 4 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xikun Li | Harbin | Heilongjiang | 150010 | China |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Aspirin Enteric-Coated Tablets | Drug | Aspirin enteric-coated tablets, 100 mg administered orally once daily. |
|
| Atorvastatin Calcium Tablets | Drug | Atorvastatin calcium tablets, 20 mg administered orally once daily. |
|
| Yixin Powder | Drug | A traditional Chinese herbal formula composed of red ginseng (5 g), pseudo-ginseng powder (3 g), dragon's blood (1 g), leech (3 g), succinite (3 g), Chinese hawthorn fruit (10 g), and myrrh (5 g). Prepared by the hospital formulary. Administered orally at a total daily dose of 30 g, divided into two 15 g portions taken morning and evening. |
|
| D000787 |
| Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |