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

ConditionsCAD - Coronary Artery DiseaseCABGERASMedicine, Chinese Traditional
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: FZYX groupExperimental treatment 1 intervention
Group B: N-FZYX groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Score of physical activity limitation dimension in the Seattle Angina Questionnaire (SAQ) at 7 days after medication

Measured using the Seattle Angina Questionnaire

Time frame
7 days after operation

Secondary outcomes

1

Length of Stay

The postoperative length of hospital stay

Time frame
Perioperative
2

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.

Time frame
up to 12 months
3

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.

Time frame
up to 12 months
4

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%).

Time frame
up to 30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: