A Randomized Controlled Trial: Fuzheng Yangxin Formula for ERAS After CABG (FZYXF-RCT-CABG)
19. august 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
230
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Gong Yichen, Doctor
- Telefonnummer: +8618611693463
- E-post: 18611693463@126.com
Studer Kontakt Backup
- Navn: Peking University 3rd Hospital cardiac surgery
Studiesteder
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Beijing, Kina
- Peking University 3rd hospital
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Ta kontakt med:
- Gong Yichen, Doctor
- Telefonnummer: +8618611693463
- E-post: 18611693463@126.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Score of physical activity limitation dimension in the Seattle Angina Questionnaire (SAQ) at 7 days after medication
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Length of Stay
Tidsramme: 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)
Tidsramme: 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
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Seattle Angina Questionnaire (SAQ) Scores
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: perioperative
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length of Intensive Care Unit (ICU) stay.
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perioperative
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
10. august 2026
Primær fullføring (Antatt)
30. november 2027
Studiet fullført (Antatt)
1. desember 2028
Datoer for studieregistrering
Først innsendt
4. august 2026
Først innsendt som oppfylte QC-kriteriene
19. august 2026
Først lagt ut (Faktiske)
24. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. august 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FZYX RCT of CABG ERAS
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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