Randomized Controlled Trial of Fuzheng Yangxin Formula in Enhanced Recovery After Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Score of physical activity limitation dimension in the Seattle Angina Questionnaire (SAQ) at 7 days after medication
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone coronary artery bypass grafting (CABG) and present with postoperative qi-yin deficiency syndrome.
排除标准
- •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.
结局指标
主要结局
Score of physical activity limitation dimension in the Seattle Angina Questionnaire (SAQ) at 7 days after medication
时间窗: 7 days after operation
Measured using the Seattle Angina Questionnaire
次要结局
- Perioperative MACCE(Perioperative)
- Length of Stay(Perioperative)
- Follow-up Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)(up to 12 months)
- Seattle Angina Questionnaire (SAQ) Scores(up to 12 months)
- Graft patency(perioperative)
- atrial fibrillation incidence(perioperative)
- Renal failure(Perioperative)
- reintubation(Perioperative)
- length of ICU stay.(perioperative)
- Incidence of poor wound healing.(up to 30 days)