A Randomized Controlled Trial: Fuzheng Yangxin Formula for ERAS After CABG (FZYXF-RCT-CABG)
19 augusti 2026 uppdaterad av: Peking University Third Hospital
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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
230
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Gong Yichen, Doctor
- Telefonnummer: +8618611693463
- E-post: 18611693463@126.com
Studera Kontakt Backup
- Namn: Peking University 3rd Hospital cardiac surgery
Studieorter
-
-
-
Beijing, Kina
- Peking University 3rd hospital
-
Kontakt:
- Gong Yichen, Doctor
- Telefonnummer: +8618611693463
- E-post: 18611693463@126.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: FZYX group
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.
|
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.
|
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Inget ingripande: N-FZYX group
Participants receive routine standard postoperative treatment after coronary artery bypass grafting (CABG).
No additional experimental herbal interventions will be provided.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Score of physical activity limitation dimension in the Seattle Angina Questionnaire (SAQ) at 7 days after medication
Tidsram: 7 days after operation
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Measured using the Seattle Angina Questionnaire
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7 days after operation
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Length of Stay
Tidsram: Perioperative
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The postoperative length of hospital stay
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Perioperative
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Follow-up Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Tidsram: up to 12 months
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The incidence of MACCE, which includes all-cause mortality, repeat bypass surgery or stenting, acute myocardial infarction, and stroke.
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up to 12 months
|
|
Seattle Angina Questionnaire (SAQ) Scores
Tidsram: up to 12 months
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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.
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up to 12 months
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Incidence of poor wound healing.
Tidsram: up to 30 days
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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%).
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up to 30 days
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Perioperative MACCE
Tidsram: Perioperative
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Composite endpoint before discharge, including death, myocardial infarction, stroke, and revascularization
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Perioperative
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Graft patency
Tidsram: perioperative
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graft patency rate (assessed by angiography)，Using the Fitz-Gibbon grading system, grade A and grade B are considered patent.
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perioperative
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atrial fibrillation incidence
Tidsram: perioperative
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Monitor patients for atrial fibrillation during hospitalization; if it occurs, it is considered positive.
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perioperative
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Renal failure
Tidsram: Perioperative
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Patients who develop new-onset renal failure after surgery and require dialysis
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Perioperative
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reintubation
Tidsram: Perioperative
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Reintubation and mechanical ventilation are required during the postoperative hospital stay
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Perioperative
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length of ICU stay.
Tidsram: perioperative
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length of Intensive Care Unit (ICU) stay.
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perioperative
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
10 augusti 2026
Primärt slutförande (Beräknad)
30 november 2027
Avslutad studie (Beräknad)
1 december 2028
Studieregistreringsdatum
Först inskickad
4 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
19 augusti 2026
Första postat (Faktisk)
24 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 augusti 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FZYX RCT of CABG ERAS
Plan för individuella deltagardata (IPD)
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NEJ
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