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NCT Number: NCT07781436

A Randomized Controlled Trial: Fuzheng Yangxin Formula for ERAS After CABG

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.

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Key information

Conditions

CAD - Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis CABG Cardiovascular Diseases Coronary Artery Disease Coronary Disease ERAS Heart Diseases Medicine, Chinese Traditional Myocardial Ischemia Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Patients who have undergone coronary artery bypass grafting (CABG) and present with postoperative qi-yin deficiency syndrome.

Exclusion criteria

  • 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.

Treatment and study plan

FZYX

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Length of Stay

    Time frame: Perioperative

    The postoperative length of hospital stay

  2. Follow-up Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

    Time frame: up to 12 months

    The incidence of MACCE, which includes all-cause mortality, repeat bypass surgery or stenting, acute myocardial infarction, and stroke.

  3. Seattle Angina Questionnaire (SAQ) Scores

    Time frame: up to 12 months

    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.

  4. Incidence of poor wound healing.

    Time frame: up to 30 days

    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%).

  5. Perioperative MACCE

    Time frame: Perioperative

    Composite endpoint before discharge, including death, myocardial infarction, stroke, and revascularization

  6. Graft patency

    Time frame: perioperative

    graft patency rate (assessed by angiography)，Using the Fitz-Gibbon grading system, grade A and grade B are considered patent.

  7. atrial fibrillation incidence

    Time frame: perioperative

    Monitor patients for atrial fibrillation during hospitalization; if it occurs, it is considered positive.

  8. Renal failure

    Time frame: Perioperative

    Patients who develop new-onset renal failure after surgery and require dialysis

  9. reintubation

    Time frame: Perioperative

    Reintubation and mechanical ventilation are required during the postoperative hospital stay

  10. length of ICU stay.

    Time frame: perioperative

    length of Intensive Care Unit (ICU) stay.

Study contacts

Contact information is provided by the study sponsor or research team.

Gong Yichen, Doctor

CONTACT

[email protected]

+8618611693463

Peking University 3rd Hospital cardiac surgery

CONTACT

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Randomized Controlled Trial of Fuzheng Yangxin Formula in Enhanced Recovery After Coronary Artery Bypass Grafting

Acronym: FZYXF-RCT-CABG

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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