Coronary Arterial Disease (CAD)Phase 4NCT07041359
Pre-trial of Clinical Trial of Traditional Chinese Medicine Treatment for Elderly Patients With Coronary Heart Disease Who Are Still Symptomatic After Optimal Medical Treatment
A Phase 4 study testing Compound Danshen Dripping Pills and Qishen Yiqi Drop Pills in people with Coronary Arterial Disease (CAD), run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
To explore the effectiveness of compound Danshen Dripping Pill and Qishen Yiqi Dripping Pill in the elderly population with coronary heart disease and the safety of multiple medications Read more about this study
- Who is it for?
- Ages 75 to 90 years
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- Compound Danshen Dripping Pills and Qishen Yiqi Drop Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 75 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 75 years old ≤ age < 90 years old, regardless of gender;
- Patients who meet the diagnostic criteria for angina pectoris, including patients with typical or atypical angina pectoris: discomfort in the anterior region is triggered by physical activity or emotional excitement and can be relieved by rest or taking nitroglycerin.Those who meet two or more of the above characteristics. After receiving conventional Western medicine treatment, the symptoms did not improve significantly or the treatment effect is poor.
- Meet the diagnostic criteria for multiple coronary artery disease with the number of coronary artery disease being greater than or equal to two (defined as angiographically the right coronary artery, left circumflex artery or left anterior descending artery stenosis rate was greater than 50%), and the patient refused or could not tolerate coronary artery revascularization or one or more coronary arteries still have a stenosis rate of ≥50% after partial revascularization;
- The patient is in line with the qi stagnation and blood stasis type or qi deficiency and blood stasis type in the TCM syndrome classification. If the results of the two syndrome differentiation are inconsistent, the TCM experts will review the syndrome differentiation, and the syndrome differentiation classification of the TCM experts shall prevail.
- The patient has good communication skills, can understand and provide relevant information required for the study, and is aware of the research purpose, content, possible risks and expected benefits can be fully provided with relevant information required for this research. Patients and their families voluntarily participated and agreed to sign the informed consent.
Who cannot join
- Those who have had acute coronary syndrome within the past month
- Acute myocardial infarction, acute myocarditis, severe arrhythmia, aortic dissecction, pericarditis, heart failure (NYHA heart function class Ⅲ or IV, EF ≤ 30%), cardiogenic shock in past 3 months or patients with chest tightness and chest pain caused by other diseases such as severe valvular disease, etc.
- Combined with acute pulmonary embolism, acute cerebral hemorrhage, polyarteritis, severe hematologic diseases, severe infectious diseases, severe immune dysfunction, malignant tumors, other organ failure or expected life expectancy less than 1 year
- Severe primary disease or severe dysfunction of the liver or kidneys（ALT levels exceeding 3.0 times the upper limit of normal or eGFR ≤30 mL/min/1.73 m²）
- Patients with severe mental disorder
- Those who are allergic to the test drug
Show all 9Show fewer
- Patients who have participated in other clinical trials in the past month
- Patients who have taken anticoagulants such as warfarin, new oral anticoagulants (NOAC) or traditional Chinese medicine preparations for promoting blood circulation and removing blood stasis in the past month
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037
Yongjian Wu, 13701387189, fuwaiwyj@163.com
About this study
To explore the effectiveness of compound Danshen Dripping Pill and Qishen Yiqi Dripping Pill in the elderly population with coronary heart disease and the safety of multiple medications
Read the detailed description
This study is a prospective, double-blind, randomized controlled clinical trial, which aims to explore the effectiveness and safety of polypharmacy in the elderly population of stable angina patients, and make up for the limitations of clinical treatment. As commonly used traditional Chinese medicine preparations, the efficacy and safety of compound Danshen Dripping Pill and Qishen Yiqi Dripping Pill have been supported by previous studies, providing a solid theoretical basis. The study design adopts scientific and reliable clinical trial methods, and the treatment plan combines Western medicine treatment and traditional Chinese medicine intervention, which has high clinical application value. In the actual clinical treatment, due to the complex medical history of elderly patients, they often have multi-vessel coronary artery lesions, and the treatment tolerance is worse than that of young people, so although they are accompanied by angina pectoris, the treatment methods are relatively limited. This study provides evidence of the efficacy and safety of drugs for the treatment of elderly patients with angina pectoris through the combination of Chinese and Western treatments, which can help make up for the dilemma of limited clinical treatment methods.
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- Compound Danshen Dripping Pills, Qishen Yiqi Drop Pills, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Danshen Dripping PillsDrug
The experimental group used compound Danshen dripping pills as an intervention on the basis of conventional western medicine treatment.
Qishen Yiqi Drop PillsDrug
The experimental group used Qishen Yiqi dripping pills as an intervention on the basis of conventional western medicine treatment.
PlaceboDrug
Intervention with placebo on the Basis of optimal medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Qi stagnation and blood stasis type control group | Placebo comparator | Intervention with placebo on the Basis of optimal medical treatment Receives: Drug: Placebo |
| Qi stagnation and blood stasis type experimental group | Experimental | Intervention with Compound Danshen Dripping Pills on the Basis of optimal medical treatment Receives: Drug: Compound Danshen Dripping Pills |
| Qi deficiency and blood stasis type control group | Placebo comparator | Intervention with placebo on the Basis of optimal medical treatment Receives: Drug: Placebo |
| Qi deficiency and blood stasis type experimental group | Experimental | Intervention with Qishen Yiqi Dropping Pills on the basis of conventional western medicine treatment Receives: Drug: Qishen Yiqi Drop Pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seattle angina questionnaire
The Seattle Angina Questionnaire (SAQ) consists of five distinct dimensions: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. Each dimension is scored independently, with a possible range of 0 to 100 points. A higher score on any SAQ dimension indicates a better patient condition or experience.
Measured: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
The Canadian Cardiovascular Society grading of angina pectoris
The Canadian Cardiovascular Society grades angina pectoris ranges from grade 1 to grade 4. Higher grade indicates worse patients' condition.
Measured: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Minnesota Living with Heart Failure Questionnaire
The Minnesota Living with Heart Failure Questionnaire's score ranges from 0 to 105. Higher score indicates worse patients' condition.
Measured: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Kansas City Cardiomyopathy Questionnaire
The Kansas City Cardiomyopathy Questionnaire's score ranges from 0 to 100. Higher score indicates better patients' condition.
Measured: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Secondary outcomes (3)
Traditional Chinese Medicine Syndrome Score
The Traditional Chinese Medicine Syndrome Score ranges from 0 to 30. Higher score indicates worse patients' condition.
Measured: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Number of angina attacks
The average number of angina attacks per week
Measured: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Nitroglycerin dosage
Patient's weekly dose of nitroglycerin, measured in mg
Measured: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start18 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041359
- Sponsor's protocol ID
- 2024-ZX080
- Status last verified
- Feb 2025
- First submitted
- 6 Jun 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-trial of Clinical Trial of Traditional Chinese Medicine Treatment for Elderly Patients With Coronary Heart Disease Who Are Still Symptomatic After Optimal Medical Treatment
- ClinicalTrials.gov ID
- NCT07041359
- Acronym / sponsor ID
- 2024-ZX080
- Conditions
- Coronary Arterial Disease (CAD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jun 2025 (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.
To explore the effectiveness of compound Danshen Dripping Pill and Qishen Yiqi Dripping Pill in the elderly population with coronary heart disease and the safety of multiple medications
Detailed description
This study is a prospective, double-blind, randomized controlled clinical trial, which aims to explore the effectiveness and safety of polypharmacy in the elderly population of stable angina patients, and make up for the limitations of clinical treatment. As commonly used traditional Chinese medicine preparations, the efficacy and safety of compound Danshen Dripping Pill and Qishen Yiqi Dripping Pill have been supported by previous studies, providing a solid theoretical basis. The study design adopts scientific and reliable clinical trial methods, and the treatment plan combines Western medicine treatment and traditional Chinese medicine intervention, which has high clinical application value. In the actual clinical treatment, due to the complex medical history of elderly patients, they often have multi-vessel coronary artery lesions, and the treatment tolerance is worse than that of young people, so although they are accompanied by angina pectoris, the treatment methods are relatively limited. This study provides evidence of the efficacy and safety of drugs for the treatment of elderly patients with angina pectoris through the combination of Chinese and Western treatments, which can help make up for the dilemma of limited clinical treatment methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Qi stagnation and blood stasis type control group | Placebo comparator | Drug: PlaceboIntervention with placebo on the Basis of optimal medical treatment |
| Qi stagnation and blood stasis type experimental group | Experimental | Drug: Compound Danshen Dripping PillsIntervention with Compound Danshen Dripping Pills on the Basis of optimal medical treatment |
| Qi deficiency and blood stasis type control group | Placebo comparator | Drug: PlaceboIntervention with placebo on the Basis of optimal medical treatment |
| Qi deficiency and blood stasis type experimental group | Experimental | Drug: Qishen Yiqi Drop PillsIntervention with Qishen Yiqi Dropping Pills on the basis of conventional western medicine treatment |
Who may qualify
- Ages
- 75 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 75 years old ≤ age < 90 years old, regardless of gender;
- Patients who meet the diagnostic criteria for angina pectoris, including patients with typical or atypical angina pectoris: discomfort in the anterior region is triggered by physical activity or emotional excitement and can be relieved by rest or taking nitroglycerin.Those who meet two or more of the above characteristics. After receiving conventional Western medicine treatment, the symptoms did not improve significantly or the treatment effect is poor.
- Meet the diagnostic criteria for multiple coronary artery disease with the number of coronary artery disease being greater than or equal to two (defined as angiographically the right coronary artery, left circumflex artery or left anterior descending artery stenosis rate was greater than 50%), and the patient refused or could not tolerate coronary artery revascularization or one or more coronary arteries still have a stenosis rate of ≥50% after partial revascularization;
- The patient is in line with the qi stagnation and blood stasis type or qi deficiency and blood stasis type in the TCM syndrome classification. If the results of the two syndrome differentiation are inconsistent, the TCM experts will review the syndrome differentiation, and the syndrome differentiation classification of the TCM experts shall prevail.
- The patient has good communication skills, can understand and provide relevant information required for the study, and is aware of the research purpose, content, possible risks and expected benefits can be fully provided with relevant information required for this research. Patients and their families voluntarily participated and agreed to sign the informed consent.
Key exclusion criteria (9 listed)
- Those who have had acute coronary syndrome within the past month
- Acute myocardial infarction, acute myocarditis, severe arrhythmia, aortic dissecction, pericarditis, heart failure (NYHA heart function class Ⅲ or IV, EF ≤ 30%), cardiogenic shock in past 3 months or patients with chest tightness and chest pain caused by other diseases such as severe valvular disease, etc.
- Combined with acute pulmonary embolism, acute cerebral hemorrhage, polyarteritis, severe hematologic diseases, severe infectious diseases, severe immune dysfunction, malignant tumors, other organ failure or expected life expectancy less than 1 year
- Severe primary disease or severe dysfunction of the liver or kidneys（ALT levels exceeding 3.0 times the upper limit of normal or eGFR ≤30 mL/min/1.73 m²）
- Patients with severe mental disorder
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 |
|---|---|---|
| Compound Danshen Dripping PillsThe experimental group used compound Danshen dripping pills as an intervention on the basis of conventional western medicine treatment. | Drug | Qi stagnation and blood stasis type experimental group |
| Qishen Yiqi Drop PillsThe experimental group used Qishen Yiqi dripping pills as an intervention on the basis of conventional western medicine treatment. | Drug | Qi deficiency and blood stasis type experimental group |
| PlaceboIntervention with placebo on the Basis of optimal medical treatment | Drug | Qi deficiency and blood stasis type control group, Qi stagnation and blood stasis type control group |
Primary outcome
Seattle angina questionnaire
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
The Seattle Angina Questionnaire (SAQ) consists of five distinct dimensions: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. Each dimension is scored independently, with a possible range of 0 to 100 points. A higher score on any SAQ dimension indicates a better patient condition or experience.
The Canadian Cardiovascular Society grading of angina pectoris
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
The Canadian Cardiovascular Society grades angina pectoris ranges from grade 1 to grade 4. Higher grade indicates worse patients' condition.
Minnesota Living with Heart Failure Questionnaire
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
The Minnesota Living with Heart Failure Questionnaire's score ranges from 0 to 105. Higher score indicates worse patients' condition.
Kansas City Cardiomyopathy Questionnaire
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
The Kansas City Cardiomyopathy Questionnaire's score ranges from 0 to 100. Higher score indicates better patients' condition.
3 secondary outcomes
Traditional Chinese Medicine Syndrome Score
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Number of angina attacks
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Nitroglycerin dosage
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compound Danshen Dripping Pills and Qishen Yiqi Drop Pills in people with Coronary Arterial Disease (CAD), run by China National Center for Cardiovascular Diseases 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seattle angina questionnaire (time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.). The study lists 4 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 29 Sep 2025.