Prospective Cohort Study on Fuzheng Yangxin Prescription For Rapid Rehabilitation of Patients With Qi-Yin Deficiency Syndrome After Coronary Artery Bypass Grafting

NCT06961136 | Recruiting

• 1 other identifier: BYSY202451303
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Coronary Artery Bypass

Keywords

Coronary Artery Bypass; Chinese herbal medicine

Outcome Measures

Primary Outcomes (1)

• SAQ scores on PL

  7days

Secondary Outcomes (2)

• Perioperative safety index

  14d

• SAQ scores on others

  12 months

Study Arms (2)

Fuzheng Yangxin prescription

Drug: Fuzheng Yangxin prescription

placebo

Drug: placebo

Interventions

Fuzheng Yangxin prescription DRUG

Fuzheng Yangxin prescription

Fuzheng Yangxin prescription

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who received coronary artery bypass surgery with syndrome differentiation of Qi-Yin deficiency after operation

You may qualify if:

• Patients who received coronary artery bypass surgery with syndrome differentiation of Qi-Yin deficiency after operation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Central Study Contacts

Yichen Gong Doctor

CONTACT

8618611693463; 18611693463@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 7, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)