Weak Pulse at Yang and Wiry Pulse at Yin Theory

NCT07378228 | Completed

• 1 other identifier: HarbinTraditionalH
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Stable Angina Pectoris

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Seattle Angina Questionnaire (SAQ) Score

  Assessed before treatment initiation and after 4 weeks of treatment.

Study Arms (2)

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.

Drug: Metoprolol Succinate Extended-Release Tablets; Drug: Aspirin Enteric-Coated Tablets; Drug: 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.

Drug: Metoprolol Succinate Extended-Release Tablets; Drug: Aspirin Enteric-Coated Tablets; Drug: Atorvastatin Calcium Tablets; Drug: Yixin Powder

Interventions

Aspirin Enteric-Coated Tablets DRUG

Aspirin enteric-coated tablets, 100 mg administered orally once daily.

Conventional Pharmacological Therapy; Conventional Therapy plus Yixin Powder

Atorvastatin Calcium Tablets DRUG

Atorvastatin calcium tablets, 20 mg administered orally once daily.

Conventional Pharmacological Therapy; Conventional Therapy plus Yixin Powder

Metoprolol Succinate Extended-Release Tablets DRUG

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

Conventional Pharmacological Therapy; Conventional Therapy plus Yixin Powder

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.

Conventional Therapy plus Yixin Powder

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xikun Li: lead

Study Sites (1)

Xikun Li

Harbin, Heilongjiang, 150010, China

Location

MeSH Terms

Conditions

Coronary Disease; Angina, Stable

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hospital Director

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 30, 2026
• Study Start: July 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)