Protocol for a randomized trial of Shenqi Yangxin Formula in stable coronary artery disease

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Frontiers in Medicine Published May 8, 2026 Medically reviewed May 8, 2026 DOI ↗ By Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

Key Takeaway

Consider this protocol as a framework for a future trial on a complementary therapy for stable coronary artery disease.

This document is a protocol for a randomized, double-blind, placebo-controlled trial. The scope is to evaluate the Shenqi Yangxin Formula (SYF) as an add-on to guideline-directed medical therapy in patients with stable coronary artery disease who meet criteria for qi deficiency and blood stasis syndrome. The trial will enroll 60 patients.

The primary outcome is changes in CCTA-derived coronary hemodynamic parameters, including CT-derived fractional flow reserve, wall shear stress, and fat attenuation index, assessed at 24 weeks. Secondary outcomes include imaging characteristics of plaques, traditional Chinese medicine syndrome scores, Seattle Angina Questionnaire scores, echocardiography, adverse cardiovascular events, and metabolomic profiles. Follow-up is scheduled at 4, 12, and 24 weeks post-randomization.

The authors note that this is a protocol, so no main results, safety data, or limitations are reported. The funding source and potential conflicts of interest are not reported. The practice relevance is described as potentially offering a complementary therapeutic strategy. Causality and certainty notes are not reported.

Study Details

Study typeGuideline

EvidenceLevel 5

PublishedMay 2026

View Original Abstract ↓

BackgroundAmong patients with stable coronary artery disease (SCAD), those with moderate coronary artery stenosis remain at high risk for adverse cardiovascular events despite optimal medical therapy. Reducing residual cardiovascular risk, particularly inflammation-related risk, is a key target for improving long-term outcomes. Evaluation of plaque burden and hemodynamics in patients with SCAD based on coronary computed tomography angiography (CCTA)-derived techniques, along with risk stratification and prediction, has become a hotspot, holding significant importance for standardizing clinical management of SCAD. Shenqi Yangxin Formula (SYF), a traditional Chinese medicine compound, has been widely used in China for SCAD and shown to alleviate symptoms, but its mechanistic benefits remain unclear. Based on this, we proposed that SYF could benefit patients with SCAD (qi deficiency and blood stasis syndrome) by reducing residual cardiovascular risk and improving coronary hemodynamics. This clinical trial was designed to objectively evaluate the efficacy and safety of SYF in SCAD.MethodsThis is a randomized, double-blind, placebo-controlled trial, enrolling 60 SCAD patients meeting criteria for qi deficiency and blood stasis syndrome. Participants are randomized 1:1 to receive SYF or placebo in addition to guideline-directed medical therapy for 12 weeks at a loading dose, followed by 12 weeks at half dose.ResultsAs of July 2024, enrollment is complete, with trial completion expected in the first quarter of 2026. The primary outcomes are changes in CCTA-derived coronary hemodynamic parameters (CT-derived fractional flow reserve, wall shear stress) and fat attenuation index at 24 weeks. Secondary outcomes include imaging characteristics of plaques, traditional chinese medicine syndrome scores, seattle angina questionnaire scores, echocardiography, adverse cardiovascular events, and metabolomic profiles. Participants undergo follow-up at 4, 12 and 24 weeks post-randomization. All data will be collected in case report forms and analyzed according to predefined statistical plans.ConclusionThis study will provide novel evidence on the efficacy and safety of SYF in improving coronary hemodynamics and reducing residual inflammatory risk in patients with SCAD and moderate stenosis, potentially offering a complementary therapeutic strategy.Clinical Trial Registrationhttp://123.57.9.4:8085/zh-CN/Home/ProjectView?pid=dbc777bb-434e-44a4-af75-cfabc32d64db, identifier ITMCTR2024000215.