Coronary Heart Disease, Stable Angina Pectoris
Conditions
Brief summary
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.
Interventions
DRUGMetoprolol Succinate Extended-Release Tablets
Metoprolol succinate extended-release tablets, 23.75 mg administered orally once daily.
Aspirin enteric-coated tablets, 100 mg administered orally once daily.
Atorvastatin calcium tablets, 20 mg administered orally once daily.
DRUGYixin Powder
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.
Sponsors
Xikun Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate based on Traditional Chinese Medicine (TCM) Syndrome Score Improvement | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seattle Angina Questionnaire (SAQ) Score | Assessed before treatment initiation and after 4 weeks of treatment. | 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. |
Countries
China
Outcome results
None listed