Efficacy and safety of Shugan Jieyu Capsule in the treatment of depressive state after acute coronary syndrome: study protocol for a multicenter randomized controlled trial.

ABSTRACT:

Objective

This study aims to evaluate the efficacy and safety of Shugan Jieyu Capsules (SGJY) in patients with depressive state after Acute Coronary Syndrome (ACS).

Methods

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 148 patients with depressive state after ACS recruited from five research centers, will be randomly assigned to either the SGJY group or the placebo group at a 1:1 ratio. In addition to standard therapies for ACS, the SGJY group will receive SGJY while the placebo group will receive a matching placebo. All participants will undergo 12 weeks of treatment, followed by 36 weeks of follow-up.

Results

The primary outcome is the Hamilton Depression Rating Scale (HAMD-17). Secondary outcomes include major advers

SUBMITTER: Yang Y 

PROVIDER: S-EPMC12571754 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature