Coronary Artery BypassNCT06961136
Prospective Cohort Study on Fuzheng Yangxin Prescription For Rapid Rehabilitation of Patients With Qi-Yin Deficiency Syndrome After Coronary Artery Bypass Grafting
An observational study of Coronary Artery Bypass, run by Peking University Third Hospital at 1 site in China.
Trial summary
Data from the Global Burden of Disease Study 2021, recently published in the Lancet, show that ischaemic heart disease remains the first most common cause of death worldwide. Ischemic heart disease mainly refers to coronary artery stenosis or obstruction caused by coronary artery atherosclerosis leading to myocardial… Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- Fuzheng Yangxin prescription
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2025to 30 Jun 2026
- Phase
- Observational
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received coronary artery bypass surgery with syndrome differentiation of Qi-Yin deficiency after operation
Who may be able to join
- Patients who received coronary artery bypass surgery with syndrome differentiation of Qi-Yin deficiency after operation
Who cannot join
- ① Patients allergic to Fuzheng Yangxin Fang granules
- Patients with postoperative cold and fever ③ Patients with severe postoperative hepatic and renal insufficiency ④ Other circumstances: Concurrent valvular surgery or other cardiac surgery, end-stage malignant tumor, uncontrolled infection, bleeding, progressive degenerative systemic disease, severe brain injury, multiple organ failure, other vital organ dysfunction such as severe liver impairment, severe heart failure or cardiogenic shock, inability to tolerate surgery, etc.
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
Peking university third hospital
Beijing, Beijing Municipality, 100191
About this study
Data from the Global Burden of Disease Study 2021, recently published in the Lancet, show that ischaemic heart disease remains the first most common cause of death worldwide. Ischemic heart disease mainly refers to coronary artery stenosis or obstruction caused by coronary artery atherosclerosis leading to myocardial ischemia heart disease, called coronary heart disease. "China Cardiovascular Health and Disease Report 2022" mentioned that coronary heart disease is an important cardiovascular disease affecting the health of Chinese residents, and its prevalence and mortality are on the rise. Coronary artery bypass grafting (CABG) and interventional therapy (PCI) are commonly used in the treatment of coronary heart disease. CABG surgery can significantly reduce the recurrence of angina pectoris, the incidence of acute myocardial infarction and improve the survival rate of patients, the patency rate of 5 years after mammary arterial bridge can reach more than 90%. Current guidelines and various RCT studies have shown that CABG is the gold standard for revascularization in patients with complex coronary artery disease. With the increasing aging of Chinese population, there are more and more cases of complex coronary artery diseases, and CABG, as the first choice for complex coronary artery diseases, will be more and more widely used in the foreseeable future. At present, the number of coronary artery bypass surgery is on the rise, about 50,000 cases per year. Traditional Chinese medicine can play a role in preventing complications, improving the quality of life and long-term curative effect of patients after CABG. It is particularly important to actively seek the treatment of integrated Chinese and Western medicine for patients after CABG. This study aims to explore the effectiveness and safety of Fuzheng Yangxin prescription in the treatment of Qi-Yin deficiency after CABG by means of a prospective cohort study, so as to determine the efficacy of Fuzheng Yangxin prescription on the recovery after CABG. To formulate a routine program of Chinese and Western combined therapy for postoperative rehabilitation of cardiac surgery, and actively promote the technology and program, promote the transformation of intellectual property rights, etc., and contribute to the formulation of relevant guidelines.
Read the detailed description
Data from the Global Burden of Disease Study 2021, recently published in the Lancet, show that ischaemic heart disease remains the first most common cause of death worldwide. Ischemic heart disease mainly refers to coronary artery stenosis or obstruction caused by coronary artery atherosclerosis leading to myocardial ischemia heart disease, called coronary heart disease. "China Cardiovascular Health and Disease Report 2022" mentioned that coronary heart disease is an important cardiovascular disease affecting the health of Chinese residents, and its prevalence and mortality are on the rise. Coronary artery bypass grafting (CABG) and interventional therapy (PCI) are commonly used in the treatment of coronary heart disease. CABG surgery can significantly reduce the recurrence of angina pectoris, the incidence of acute myocardial infarction and improve the survival rate of patients, the patency rate of 5 years after mammary arterial bridge can reach more than 90%. Current guidelines and various RCT studies have shown that CABG is the gold standard for revascularization in patients with complex coronary artery disease. With the increasing aging of Chinese population, there are more and more cases of complex coronary artery diseases, and CABG, as the first choice for complex coronary artery diseases, will be more and more widely used in the foreseeable future. At present, the number of coronary artery bypass surgery is on the rise, about 50,000 cases per year.
Although CABG surgery has a better long-term survival rate for patients with complex lesions, no matter what method of CABG surgery, it will inevitably cause a large blow to patients and bring a huge burden on patients' physiological and psychological functions in the early postoperative period. In the SYNTAX trial, The physiological function scores (SF-36 and EQ-5D) of the patients after CABG were significantly lower than those after PCI. Another RCT study, the FREEDOM trial, showed that although CABG had a good quality of life and physiological status 12 months after surgery, compared with PCI, CABG quality of life and psychological status scores were significantly lower at 6 months after surgery. These trials suggest that patients with CABG face an early recovery challenge due to surgical trauma. And as the number of older adults receiving CABG increases, the problem is likely to get worse. At the same time, there are many postoperative complications such as myocardial infarction, heart failure and atrial fibrillation after CABG.
Traditional Chinese medicine can play a role in preventing complications, improving the quality of life and long-term curative effect of patients after CABG. It is particularly important to actively seek the treatment of integrated Chinese and Western medicine for patients after CABG. This study aims to explore the effectiveness and safety of Fuzheng Yangxin prescription in the treatment of Qi-Yin deficiency after CABG by means of a prospective cohort study, so as to determine the efficacy of Fuzheng Yangxin prescription on the recovery after CABG. To formulate a routine program of Chinese and Western combined therapy for postoperative rehabilitation of cardiac surgery, and actively promote the technology and program, promote the transformation of intellectual property rights, etc., and contribute to the formulation of relevant guidelines.
If this study confirms the effectiveness and safety of Fuzheng Yangxin prescription in treating Qi-Yin deficiency syndrome after CABG operation, it can significantly improve patients' quality of life and shorten hospitalization and rehabilitation time, which can benefit more patients, significantly reduce medical costs and reduce the burden of medical insurance, and contribute to the implementation of the Healthy China strategy. At the same time, through the promotion of this project, it is expected to promote the cooperation between traditional Chinese and Western medicine after cardiac surgery, form a routine program and promote it, accelerate the transformation of intellectual property rights, and promote the construction of the "flagship" hospital of traditional Chinese and Western medicine cooperation in Peking University Third Hospital.
- Conditions
- Coronary Artery Bypass
- Being tested
- Fuzheng Yangxin prescription, placebo
- Keywords
- Coronary Artery Bypass, Chinese herbal medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuzheng Yangxin prescriptionDrug
Fuzheng Yangxin prescription
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Fuzheng Yangxin prescription | Not described Receives: Drug: Fuzheng Yangxin prescription | |
| placebo | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAQ scores on PL
Measured: 7days
Secondary outcomes (2)
Perioperative safety index
Measured: 14d
SAQ scores on others
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start10 May 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961136
- Sponsor's protocol ID
- BYSY202451303
- Status last verified
- Feb 2026
- First submitted
- 29 Apr 2025
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu J, Wang Y, Li Y, Ding T, Meng L, Ma X, Ling Y, Gong Y. Efficacy, safety, and transcriptomic mechanisms of Fuzheng Yangxin formula for enhanced recovery after coronary artery bypass grafting: a propensity score-matched prospective cohort study. Front Med (Lausanne). 2026 Aug 12;13:1902379. doi: 10.3389/fmed.2026.1902379. eCollection 2026.
PubMed 42656530
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Fuzheng Yangxin Prescription For Rapid Rehabilitation of Patients With Qi-Yin Deficiency Syndrome After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT06961136
- Acronym / sponsor ID
- BYSY202451303
- Conditions
- Coronary Artery Bypass
- Keywords
- Coronary Artery Bypass, Chinese herbal medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 10 May 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 May 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.
Data from the Global Burden of Disease Study 2021, recently published in the Lancet, show that ischaemic heart disease remains the first most common cause of death worldwide. Ischemic heart disease mainly refers to coronary artery stenosis or obstruction caused by coronary artery atherosclerosis leading to myocardial ischemia heart disease, called coronary heart disease. "China Cardiovascular Health and Disease Report 2022" mentioned that coronary heart disease is an important cardiovascular disease affecting the health of Chinese residents, and its prevalence and mortality are on the rise. Coronary artery bypass grafting (CABG) and interventional therapy (PCI) are commonly used in the treatment of coronary heart disease. CABG surgery can significantly reduce the recurrence of angina pectoris, the incidence of acute myocardial infarction and improve the survival rate of patients, the patency rate of 5 years after mammary arterial bridge can reach more than 90%. Current guidelines and various RCT studies have shown that CABG is the gold standard for revascularization in patients with complex coronary artery disease. With the increasing aging of Chinese population, there are more and more cases of complex coronary artery diseases, and CABG, as the first choice for complex coronary artery diseases, will be more and more widely used in the foreseeable future. At present, the number of coronary artery bypass surgery is on the rise, about 50,000 cases per year. Traditional Chinese medicine can play a role in preventing complications, improving the quality of life and long-term curative effect of patients after CABG. It is particularly important to actively seek the treatment of integrated Chinese and Western medicine for patients after CABG. This study aims to explore the effectiveness and safety of Fuzheng Yangxin prescription in the treatment of Qi-Yin deficiency after CABG by means of a prospective cohort study, so as to determine the efficacy of Fuzheng Yangxin prescription on the recovery after CABG. To formulate a routine program of Chinese and Western combined therapy for postoperative rehabilitation of cardiac surgery, and actively promote the technology and program, promote the transformation of intellectual property rights, etc., and contribute to the formulation of relevant guidelines.
Detailed description
Data from the Global Burden of Disease Study 2021, recently published in the Lancet, show that ischaemic heart disease remains the first most common cause of death worldwide. Ischemic heart disease mainly refers to coronary artery stenosis or obstruction caused by coronary artery atherosclerosis leading to myocardial ischemia heart disease, called coronary heart disease. "China Cardiovascular Health and Disease Report 2022" mentioned that coronary heart disease is an important cardiovascular disease affecting the health of Chinese residents, and its prevalence and mortality are on the rise. Coronary artery bypass grafting (CABG) and interventional therapy (PCI) are commonly used in the treatment of coronary heart disease. CABG surgery can significantly reduce the recurrence of angina pectoris, the incidence of acute myocardial infarction and improve the survival rate of patients, the patency rate of 5 years after mammary arterial bridge can reach more than 90%. Current guidelines and various RCT studies have shown that CABG is the gold standard for revascularization in patients with complex coronary artery disease. With the increasing aging of Chinese population, there are more and more cases of complex coronary artery diseases, and CABG, as the first choice for complex coronary artery diseases, will be more and more widely used in the foreseeable future. At present, the number of coronary artery bypass surgery is on the rise, about 50,000 cases per year.
Although CABG surgery has a better long-term survival rate for patients with complex lesions, no matter what method of CABG surgery, it will inevitably cause a large blow to patients and bring a huge burden on patients' physiological and psychological functions in the early postoperative period. In the SYNTAX trial, The physiological function scores (SF-36 and EQ-5D) of the patients after CABG were significantly lower than those after PCI. Another RCT study, the FREEDOM trial, showed that although CABG had a good quality of life and physiological status 12 months after surgery, compared with PCI, CABG quality of life and psychological status scores were significantly lower at 6 months after surgery. These trials suggest that patients with CABG face an early recovery challenge due to surgical trauma. And as the number of older adults receiving CABG increases, the problem is likely to get worse. At the same time, there are many postoperative complications such as myocardial infarction, heart failure and atrial fibrillation after CABG.
Traditional Chinese medicine can play a role in preventing complications, improving the quality of life and long-term curative effect of patients after CABG. It is particularly important to actively seek the treatment of integrated Chinese and Western medicine for patients after CABG. This study aims to explore the effectiveness and safety of Fuzheng Yangxin prescription in the treatment of Qi-Yin deficiency after CABG by means of a prospective cohort study, so as to determine the efficacy of Fuzheng Yangxin prescription on the recovery after CABG. To formulate a routine program of Chinese and Western combined therapy for postoperative rehabilitation of cardiac surgery, and actively promote the technology and program, promote the transformation of intellectual property rights, etc., and contribute to the formulation of relevant guidelines.
If this study confirms the effectiveness and safety of Fuzheng Yangxin prescription in treating Qi-Yin deficiency syndrome after CABG operation, it can significantly improve patients' quality of life and shorten hospitalization and rehabilitation time, which can benefit more patients, significantly reduce medical costs and reduce the burden of medical insurance, and contribute to the implementation of the Healthy China strategy. At the same time, through the promotion of this project, it is expected to promote the cooperation between traditional Chinese and Western medicine after cardiac surgery, form a routine program and promote it, accelerate the transformation of intellectual property rights, and promote the construction of the "flagship" hospital of traditional Chinese and Western medicine cooperation in Peking University Third Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fuzheng Yangxin prescription | – | Drug: Fuzheng Yangxin prescription |
| placebo | – | Drug: placebo |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received coronary artery bypass surgery with syndrome differentiation of Qi-Yin deficiency after operation
Key inclusion criteria (1 listed)
- Patients who received coronary artery bypass surgery with syndrome differentiation of Qi-Yin deficiency after operation
Key exclusion criteria (2 listed)
- ① Patients allergic to Fuzheng Yangxin Fang granules
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 |
|---|---|---|
| Fuzheng Yangxin prescriptionFuzheng Yangxin prescription | Drug | Fuzheng Yangxin prescription |
| placeboplacebo | Drug | placebo |
Primary outcome
SAQ scores on PL
Time frame: 7days
2 secondary outcomes
Perioperative safety index
Time frame: 14d
SAQ scores on others
Time frame: 12 months
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 8 May 2026.
- Derived from this study: PubMed 42656530Yu J, Wang Y, Li Y, Ding T, Meng L, Ma X, Ling Y, Gong Y. Efficacy, safety, and transcriptomic mechanisms of Fuzheng Yangxin formula for enhanced recovery after coronary artery bypass grafting: a propensity score-matched prospective cohort study. Front Med (Lausanne). 2026 Aug 12;13:1902379. doi: 10.3389/fmed.2026.1902379. eCollection 2026.
- Individual participant dataSharing planned: No
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Coronary Artery Bypass Graft (CABG)
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?
An observational study of Coronary Artery Bypass, run by Peking University Third Hospital 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 1 inclusion and 2 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 8 May 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?
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?
Contact Yichen Gong Doctor (8618611693463, 18611693463@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAQ scores on PL (time frame: 7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06961136, which also lists 1 linked publication.
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 8 May 2026.