CAD - Coronary Artery DiseaseFZYXF-RCT-CABGNCT07781436
A Randomized Controlled Trial: Fuzheng Yangxin Formula for ERAS After CABG
A study testing FZYX in people with CAD - Coronary Artery Disease and CABG, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of Fuzheng Yangxin Formula (FZYXF) in the treatment of qi-yin deficiency syndrome after coronary artery bypass grafting (CABG), formulate an integrated Chinese and Western medicine rehabilitation protocol, develop special proprietary Chinese medicines for… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- CAD - Coronary Artery Disease, CABG, ERAS
- What is being tested?
- FZYX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2026to 1 Dec 2028
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients who have undergone coronary artery bypass grafting (CABG) and present with postoperative qi-yin deficiency syndrome.
Who cannot join
- Patients with hypersensitivity to any components of Fuzheng Yangxin Formula granules.
- Patients with fever or common cold after surgery.
- Patients with severe postoperative liver and kidney dysfunction.
- Patients who receive concurrent valve surgery or other intracardiac operations
- Patients with end-stage malignant tumors
- Patients with uncontrolled infection or bleeding
- Patients with progressive degenerative systemic diseases, such as severe trauma, multiple organ failure and other severe impairment of vital organ function including severely damaged liver function
- Patients with severe heart failure or cardiogenic shock who cannot tolerate treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peking University 3rd Hospital cardiac surgery contact
China1 site
Peking University 3rd hospital
Beijing
Gong Yichen, Doctor, +8618611693463, 18611693463@126.com
About this study
Official title: Randomized Controlled Trial of Fuzheng Yangxin Formula in Enhanced Recovery After Coronary Artery Bypass Grafting
This study aims to evaluate the efficacy and safety of Fuzheng Yangxin Formula (FZYXF) in the treatment of qi-yin deficiency syndrome after coronary artery bypass grafting (CABG), formulate an integrated Chinese and Western medicine rehabilitation protocol, develop special proprietary Chinese medicines for postoperative patients, establish a postoperative rehabilitation database, and promote the standardized application and achievement transformation of integrated Chinese and Western medicine therapy in cardiac surgery.
Read the detailed description
This study adopts a randomized controlled trial design. A total of 230 patients presenting with qi-yin deficiency syndrome after coronary artery bypass grafting (CABG) will be enrolled and randomly assigned to the Fuzheng Yangxin Formula (FZYXF) experimental group (115 patients) and the control group (115 patients). The primary outcome is the Seattle Angina Questionnaire (SAQ) score at 7 days after medication. Secondary outcomes include perioperative safety and follow-up health assessments to comprehensively evaluate the therapeutic efficacy and safety.
- Being tested
- FZYX
- Keywords
- CABG, ERAS, MICS-CABG, Chinese traditional medicine
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FZYXDrug
Intervention: Fuzheng Yangxin Formula granules combined with routine postoperative management. The formula consists of Radix Ginseng 20 g, processed Radix Aconiti Lateralis Preparata 10 g (pre-decocted), Radix Astragali 30 g, Radix Ophiopogonis 20 g, Radix Angelicae Sinensis 15 g, Radix Rehmanniae 15 g, Radix Rhodiolae 30 g, Radix Notoginseng powder 6 g (mixed with warm water for oral use). Participants take the granules orally for 7 consecutive days after CABG.
| Study group | Role | What they receive |
|---|---|---|
| FZYX group | Experimental | Intervention: Fuzheng Yangxin Formula granules combined with routine postoperative management. The formula consists of Radix Ginseng 20 g, processed Radix Aconiti Lateralis Preparata 10 g (pre-decocted), Radix Astragali 30 g, Radix Ophiopogonis 20 g, Radix Angelicae Sinensis 15 g, Radix Rehmanniae 15 g, Radix Rhodiolae 30 g, Radix Notoginseng powder 6 g (mixed with warm water for oral use). Participants take the granules orally for 7 consecutive days after CABG. Receives: Drug: FZYX |
| N-FZYX group | No intervention | Participants receive routine standard postoperative treatment after coronary artery bypass grafting (CABG). No additional experimental herbal interventions will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of physical activity limitation dimension in the Seattle Angina Questionnaire (SAQ) at 7 days after medication
Measured using the Seattle Angina Questionnaire
Measured: 7 days after operation
Secondary outcomes (10)
Length of Stay
The postoperative length of hospital stay
Measured: Perioperative
Follow-up Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
The incidence of MACCE, which includes all-cause mortality, repeat bypass surgery or stenting, acute myocardial infarction, and stroke.
Measured: up to 12 months
Seattle Angina Questionnaire (SAQ) Scores
Evaluation of the patient's health and angina status, including the total score and scores across 5 dimensions: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception.
Measured: up to 12 months
Incidence of poor wound healing.
Assessed by routine postoperative clinical physical examination. A positive event is defined as the presence of any of the following: local wound dehiscence (splitting open), abnormal wound exudate (purulent or serous drainage), or the need for secondary surgical suturing/re-suturing. Number and percentage of participants with poor wound healing (number of events / total participants in group × 100%).
Measured: up to 30 days
Perioperative MACCE
Composite endpoint before discharge, including death, myocardial infarction, stroke, and revascularization
Measured: Perioperative
Graft patency
graft patency rate (assessed by angiography)，Using the Fitz-Gibbon grading system, grade A and grade B are considered patent.
Measured: perioperative
atrial fibrillation incidence
Monitor patients for atrial fibrillation during hospitalization; if it occurs, it is considered positive.
Measured: perioperative
Renal failure
Patients who develop new-onset renal failure after surgery and require dialysis
Measured: Perioperative
reintubation
Reintubation and mechanical ventilation are required during the postoperative hospital stay
Measured: Perioperative
length of ICU stay.
length of Intensive Care Unit (ICU) stay.
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD - Coronary Artery 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 230 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
- NCT07781436
- Sponsor's protocol ID
- FZYX RCT of CABG ERAS
- Acronym
- FZYXF-RCT-CABG
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2026
- Last updated
- 24 Aug 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Fuzheng Yangxin Formula in Enhanced Recovery After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT07781436
- Acronym / sponsor ID
- FZYXF-RCT-CABG / FZYX RCT of CABG ERAS
- Keywords
- CABG, ERAS, MICS-CABG, Chinese traditional medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 24 Aug 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 study aims to evaluate the efficacy and safety of Fuzheng Yangxin Formula (FZYXF) in the treatment of qi-yin deficiency syndrome after coronary artery bypass grafting (CABG), formulate an integrated Chinese and Western medicine rehabilitation protocol, develop special proprietary Chinese medicines for postoperative patients, establish a postoperative rehabilitation database, and promote the standardized application and achievement transformation of integrated Chinese and Western medicine therapy in cardiac surgery.
Detailed description
This study adopts a randomized controlled trial design. A total of 230 patients presenting with qi-yin deficiency syndrome after coronary artery bypass grafting (CABG) will be enrolled and randomly assigned to the Fuzheng Yangxin Formula (FZYXF) experimental group (115 patients) and the control group (115 patients). The primary outcome is the Seattle Angina Questionnaire (SAQ) score at 7 days after medication. Secondary outcomes include perioperative safety and follow-up health assessments to comprehensively evaluate the therapeutic efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FZYX group | Experimental | Drug: FZYXIntervention: Fuzheng Yangxin Formula granules combined with routine postoperative management. The formula consists of Radix Ginseng 20 g, processed Radix Aconiti Lateralis Preparata 10 g (pre-decocted), Radix Astragali 30 g, Radix Ophiopogonis 20 g, Radix Angelicae Sinensis 15 g, Radix Rehmanniae 15 g, Radix Rhodiolae 30 g, Radix Notoginseng powder 6 g (mixed with warm water for oral use). Participants take the granules orally for 7 consecutive days after CABG. |
| N-FZYX group | No intervention | –Participants receive routine standard postoperative treatment after coronary artery bypass grafting (CABG). No additional experimental herbal interventions will be provided. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients who have undergone coronary artery bypass grafting (CABG) and present with postoperative qi-yin deficiency syndrome.
Key exclusion criteria (8 listed)
- Patients with hypersensitivity to any components of Fuzheng Yangxin Formula granules.
- Patients with fever or common cold after surgery.
- Patients with severe postoperative liver and kidney dysfunction.
- Patients who receive concurrent valve surgery or other intracardiac operations
- Patients with end-stage malignant tumors
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 |
|---|---|---|
| FZYXIntervention: Fuzheng Yangxin Formula granules combined with routine postoperative management. The formula consists of Radix Ginseng 20 g, processed Radix Aconiti Lateralis Preparata 10 g (pre-decocted), Radix Astragali 30 g, Radix Ophiopogonis 20 g, Radix Angelicae Sinensis 15 g, Radix Rehmanniae 15 g, Radix Rhodiolae 30 g, Radix Notoginseng powder 6 g (mixed with warm water for oral use). Participants take the granules orally for 7 consecutive days after CABG. | Drug | FZYX group |
Primary outcome
Score of physical activity limitation dimension in the Seattle Angina Questionnaire (SAQ) at 7 days after medication
Time frame: 7 days after operation
Measured using the Seattle Angina Questionnaire
10 secondary outcomes
Length of Stay
Time frame: Perioperative
Follow-up Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: up to 12 months
Seattle Angina Questionnaire (SAQ) Scores
Time frame: up to 12 months
Incidence of poor wound healing.
Time frame: up to 30 days
Perioperative MACCE
Time frame: Perioperative
Graft patency
Time frame: perioperative
atrial fibrillation incidence
Time frame: perioperative
Renal failure
Time frame: Perioperative
reintubation
Time frame: Perioperative
length of ICU stay.
Time frame: perioperative
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 24 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for CAD - Coronary Artery Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
Active, not recruitingPhase 4
Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
Coronary Artery Disease, Atherosclerosis of Coronary Artery
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.
Peking University 3rd Hospital cardiac surgery contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FZYX in people with CAD - Coronary Artery Disease and CABG, 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 8 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: opening soon, as of the sponsor's last update on 24 Aug 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 Gong Yichen, 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?
Score of physical activity limitation dimension in the Seattle Angina Questionnaire (SAQ) at 7 days after medication (time frame: 7 days after operation). 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 24 Aug 2026.