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NCT Number: NCT07378228

Weak Pulse at Yang and Wiry Pulse at Yin Theory

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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Key information

Conditions

Coronary Heart Disease Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stable Angina Pectoris Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xikun Li

Harbin, Heilongjiang, 150010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metoprolol Succinate Extended-Release Tablets

Drug

Metoprolol succinate extended-release tablets, 23.75 mg administered orally once daily.

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.

Primary outcomes

  1. Response Rate based on Traditional Chinese Medicine (TCM) Syndrome Score Improvement

    Time frame: 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.

  2. Response Rate based on Electrocardiogram (ECG) Improvement

    Time frame: 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 outcomes

  1. Seattle Angina Questionnaire (SAQ) Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xikun Li

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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