Coronary Heart DiseaseNCT07378228
Weak Pulse at Yang and Wiry Pulse at Yin Theory
A study testing Metoprolol Succinate Extended-Release Tablets, Aspirin Enteric-Coated Tablets and Atorvastatin Calcium Tablets in people with Coronary Heart Disease and Stable Angina Pectoris, run by Xikun Li at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Coronary Heart Disease, Stable Angina Pectoris
- What is being tested?
- Metoprolol Succinate Extended-Release Tablets, Aspirin Enteric-Coated Tablets and Atorvastatin Calcium Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Metoprolol Succinate Extended-Release Tablets, Aspirin Enteric-Coated Tablets, Atorvastatin Calcium Tablets, Yixin Powder
- Medical subject headings
- Coronary Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol Succinate Extended-Release TabletsDrug
Metoprolol succinate extended-release tablets, 23.75 mg administered orally once daily.
Aspirin Enteric-Coated TabletsDrug
Aspirin enteric-coated tablets, 100 mg administered orally once daily.
Atorvastatin Calcium TabletsDrug
Atorvastatin calcium tablets, 20 mg administered orally once daily.
Yixin PowderDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Metoprolol Succinate Extended-Release Tablets; Drug: Aspirin Enteric-Coated Tablets; Drug: Atorvastatin Calcium Tablets; Drug: Yixin Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed before treatment initiation and after 4 weeks of treatment.
Secondary outcomes (1)
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.
Measured: Assessed before treatment initiation and after 4 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Jul 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xikun Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xikun Li, Harbin Traditional Chinese Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378228
- Sponsor's protocol ID
- HarbinTraditionalH
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07378228
- Acronym / sponsor ID
- HarbinTraditionalH
- Conditions
- Coronary Heart Disease, Stable Angina Pectoris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Xikun LiUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Pharmacological Therapy | Active comparator | Drug: Metoprolol Succinate Extended-Release Tablets, Drug: Aspirin Enteric-Coated Tablets, Drug: Atorvastatin Calcium TabletsParticipants 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. |
| Conventional Therapy plus Yixin Powder | Experimental | Drug: Metoprolol Succinate Extended-Release Tablets, Drug: Aspirin Enteric-Coated Tablets, Drug: Atorvastatin Calcium Tablets, Drug: Yixin PowderParticipants 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metoprolol Succinate Extended-Release TabletsMetoprolol succinate extended-release tablets, 23.75 mg administered orally once daily. | Drug | Conventional Pharmacological Therapy, Conventional Therapy plus Yixin Powder |
| Aspirin Enteric-Coated TabletsAspirin enteric-coated tablets, 100 mg administered orally once daily. | Drug | Conventional Pharmacological Therapy, Conventional Therapy plus Yixin Powder |
| Atorvastatin Calcium TabletsAtorvastatin calcium tablets, 20 mg administered orally once daily. | Drug | Conventional Pharmacological Therapy, Conventional Therapy plus Yixin Powder |
| Yixin PowderA 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. | Drug | Conventional Therapy plus Yixin Powder |
Primary outcome
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.
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.
1 secondary outcome
Seattle Angina Questionnaire (SAQ) Score
Time frame: Assessed before treatment initiation and after 4 weeks of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metoprolol Succinate Extended-Release Tablets, Aspirin Enteric-Coated Tablets and Atorvastatin Calcium Tablets in people with Coronary Heart Disease and Stable Angina Pectoris, run by Xikun Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate based on Traditional Chinese Medicine (TCM) Syndrome Score Improvement (time frame: Assessed before treatment initiation and after 4 weeks of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.