Clinical Application and Mechanistic Study of National Traditional Chinese Medicine Master Lu Fang's "Weak Pulse at Yang and Wiry Pulse at Yin" Theory in Treating Angina Pectoris of qi Deficiency and Blood Stasis Pattern Secondary to Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Response Rate based on Traditional Chinese Medicine (TCM) Syndrome Score Improvement
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CHD-induced stable angina pectoris according to Western medicine diagnostic criteria；
- •Diagnosis of qi deficiency and blood stasis pattern according to TCM pattern differentiation;
- •Age between 40 and 70 years, regardless of sex;
- •Stable vital signs and normal liver and renal function before enrollment;
- •Angina severity graded between I and III;
- •Voluntary participation with signed informed consent.
排除标准
- •Uncontrolled severe hypertension (BP ≥180/110 mmHg);
- •Severe comorbid conditions involving major organs or systems, including heart, brain, liver, or kidneys;
- •Known allergy to, or intolerance of, any of the study medications; (3) Presence of psychiatric disorders;
- •Requirement for long-term use of medications that could interfere with study outcomes;
- •Coexisting infectious diseases.
研究组 & 干预措施
Conventional Pharmacological Therapy
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.
干预措施: Metoprolol Succinate Extended-Release Tablets (Drug)
Conventional Pharmacological Therapy
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.
干预措施: Aspirin Enteric-Coated Tablets (Drug)
Conventional Pharmacological Therapy
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.
干预措施: Atorvastatin Calcium Tablets (Drug)
Conventional Therapy plus Yixin Powder
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.
干预措施: Metoprolol Succinate Extended-Release Tablets (Drug)
Conventional Therapy plus Yixin Powder
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.
干预措施: Aspirin Enteric-Coated Tablets (Drug)
Conventional Therapy plus Yixin Powder
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.
干预措施: Atorvastatin Calcium Tablets (Drug)
Conventional Therapy plus Yixin Powder
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.
干预措施: Yixin Powder (Drug)
结局指标
主要结局
Response Rate based on Traditional Chinese Medicine (TCM) Syndrome Score Improvement
时间窗: Assessed before treatment initiation and after 4 weeks of treatment.
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.
Response Rate based on Electrocardiogram (ECG) Improvement
时间窗: Assessed before treatment initiation and after 4 weeks of treatment.
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.
次要结局
- Seattle Angina Questionnaire (SAQ) Score(Assessed before treatment initiation and after 4 weeks of treatment.)
研究者
Xikun Li
Hospital Director
Harbin Traditional Chinese Medicine Hospital