NCT07781436

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Aug 2026Dec 2028

First Submitted

Initial submission to the registry

August 4, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

August 10, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 24, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

August 4, 2026

Last Update Submit

August 19, 2026

Conditions

CAD - Coronary Artery DiseaseCABGERASMedicine, Chinese Traditional

Keywords

CABGERASMICS-CABGChinese traditional medicine

Outcome Measures

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

    7 days after operation

Secondary Outcomes (10)

  • 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

  • Incidence of poor wound healing.

    up to 30 days

  • Perioperative MACCE

    Perioperative

  • +5 more secondary outcomes

Study Arms (2)

FZYX group

EXPERIMENTAL

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.

Drug: FZYX

N-FZYX group

NO INTERVENTION

Participants receive routine standard postoperative treatment after coronary artery bypass grafting (CABG). No additional experimental herbal interventions will be provided.

Interventions

FZYXDRUG

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.

FZYX group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have undergone coronary artery bypass grafting (CABG) and present with postoperative qi-yin deficiency syndrome.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University 3rd hospital

Beijing, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Gong Yichen, Doctor

CONTACT

+861861169346318611693463@126.com

Peking University 3rd Hospital cardiac surgery

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 24, 2026

Study Start

August 10, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

August 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)