Weak Pulse at Yang and Wiry Pulse at Yin Theory

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease; Stable Angina Pectoris
• Intervention / Treatment: Drug: Metoprolol Succinate Extended-Release Tablets; Drug: Aspirin Enteric-Coated Tablets; Drug: Atorvastatin Calcium Tablets; Drug: Yixin Powder

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150010
      • Xikun Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Metoprolol Succinate Extended-Release Tablets; Metoprolol succinate extended-release tablets, 23.75 mg administered orally once daily.; Drug: Aspirin Enteric-Coated Tablets; Aspirin enteric-coated tablets, 100 mg administered orally once daily.; Drug: Atorvastatin Calcium Tablets; Atorvastatin calcium tablets, 20 mg administered orally once daily.
Experimental: 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.	Drug: Metoprolol Succinate Extended-Release Tablets; Metoprolol succinate extended-release tablets, 23.75 mg administered orally once daily.; Drug: Aspirin Enteric-Coated Tablets; Aspirin enteric-coated tablets, 100 mg administered orally once daily.; Drug: Atorvastatin Calcium Tablets; Atorvastatin calcium tablets, 20 mg administered orally once daily.; Drug: Yixin 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Xikun Li

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Chest Pain; Angina Pectoris; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Coronary Disease; Angina, Stable; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Azoles; Pyrroles; Heptanoic Acids; Atorvastatin
• Other Study ID Numbers: HarbinTraditionalH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No