NCT07478328

Chaigui Longmu Ejiao Paste for Ischemic Heart Disease

A Randomized, Double-Blind Clinical Trial of Chaigui Longmu Ejiao Paste in the Treatment of Ischemic Heart Disease With Internal and External Controls

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Longhua Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study explores whether Chaigui Longmu Ejiao Paste can reduce the average weekly number of angina attacks in patients with ischemic heart disease after 8 weeks of treatment, using Chaigui Longmu Paste without Ejiao as a parallel control and incorporating a synthesized external control.

Detailed description

Overall Study Design: This is a randomized, double-blind clinical trial with internal and external controls. Trial Procedure: The study includes a screening/baseline period, an 8-week treatment period, and a 4-week follow-up period. The end-of-study/end-of-treatment visit (EOS/EOT) is performed at 12 weeks after treatment initiation. Randomization and Blinding: Block randomization is applied, with a 1:1 allocation ratio across groups. The trial is double-blinded. External Control: Literature data (external control derived from published literature). Data Collection: Data are collected using an Electronic Data Capture (EDC) system in combination with an electronic Patient-Reported Outcomes (ePRO) system.

Conditions

• Ischemic Heart Disease

Interventions

Type	Name	Description
DRUG	Standard Western medicine treatment + Chaigui Longmu Ejiao Paste	15 g orally twice daily
DRUG	Placebo Comparator: Standard Western medicine treatment + Chaigui Longmu Paste without Ejiao	15 g orally twice daily

Timeline

• Start date: 2026-03-08
• Primary completion: 2027-03-31
• Completion: 2028-12-31
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: China