NCT06686355

The Treatment of Sepsis Induced Myocardial Dysfunction With Yiqilishui Formula

Double-blind Randomized Parallel Contrast Clinical Study of Yiqilishui Formula on Sepsis Induced Myocardial Dysfunction

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Dongzhimen Hospital, Beijing · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if Chinese medicine - Yiqilishui formula works to treat sepsis-induced myocardial dysfunction (SIMD). It will also learn about the safety of Yiqilishui formula. The main questions it aims to answer are: * Compared with conventional western traetment alone, can supplementing conventional Western treatment with Yiqilishui formula better improve the heart function and reduce mortality of participants with SIMD? * What medical problems do participants have when taking Yiqilishui formula? Researchers will compare Yiqilishui formula to a placebo (a look-alike substance that contains no drug) to see if Yiqilishui formula works to treat SIMD. Participants will: * Take Yiqilishui formula granules or placebo twice daily for 7 days, while receiving standard conventional Western treatment. * Undergo blood drawing, electrocardiogram and transthoracic echocardiography at enrollment, on the 3rd day, the 7th day, and the 14th day after enrollment.

Detailed description

Sepsis-induced myocardial dysfunction (SIMD) is characterized by high morbidity and mortality rates and remains a challenging issue in the field of critical care that has not yet been resolved. The main pathogenesis involves deficiency of Qi with water overflow and blood stasis and toxin blocking the channels. The use of a Qi-invigorating and diuretic formula has the effect of invigorating Qi, promoting diuresis, and detoxifying and unblocking the channels. This study employed a two-center prospective parallel randomized double-blind controlled trial, selecting a total of 80 SIMD subjects from the ICU of Tongzhou District Traditional Chinese Medicine Hospital and the ICU of Dongzhimen Hospital of Beijing University of Chinese Medicine, who met the inclusion and exclusion criteria. The subjects were randomly and evenly divided into a treatment group and a control group. Both groups received basic SIMD treatment, with the treatment group additionally receiving the oral or nasogastric administration of a granule preparation of Yiqilishui formula, and the control group receiving a placebo orally or nasogastrically. The intervention period was 7 days, with a follow-up period of 28 days. The primary efficacy indicators compared between the two groups were BNP and NT-proBNP, and the secondary efficacy indicators were echocardiography, myocardial injury markers, inflammatory markers, critical illness severity scores, ICU length of stay and costs, and 28-day survival rate. The study aimed to evaluate the clinical efficacy and safety of the Yiqilishui formula for SIMD.

Conditions

• Sepsis Induced Myocardial Dysfunction

Interventions

Type	Name	Description
DRUG	Yiqilishui formula	Astragalus Root 30g, Angelica sinensis 30g, Honeysuckle Flower 30g, Capillary Artemisia Herb 15g, Giant Knotweed Rhizome 15g, Lepidium Seed 30g, Sichuan Lovage Rhizome 15g, Salvia Root 15g, Jujube Fruit 15g;
OTHER	Placebo	5% Yiqilishui Granules + 95% Dextrin;

Timeline

• Start date: 2024-11-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-11-13
• Last updated: 2026-03-30

Locations

1 site across 1 country: China