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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients hospitalized in the ICU of Tongzhou Traditional Chinese Medicine Hospital and Dongzhimen Hospital of Beijing University of Chinese Medicine between January 2024 and December 2026.

• Patients diagnosed with SIMD and qi deficiency and water flooding syndrome.

• Aged 50 to 80 years.

• SOFA score: 2 to 12 points.

• Diagnosis of SIMD within 24 hours.

• Signed informed consent by the patient or their family.

Locations
Other Locations
China
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
RECRUITING
Beijing
Contact Information
Primary
XIU
a2w029@bucm.edu.cn
+86-010-84013192
Time Frame
Start Date: 2024-11-20
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 80
Treatments
Experimental: Yiqilishui group
Conventional Western medicine treatment + oral or nasogastric administration of Yiqilishui formula granules, twice daily;
Sham_comparator: placebo group
Conventional Western medicine treatment + oral or nasal feeding of Yiqilishui formula placebo , twice daily.
Related Therapeutic Areas
Sponsors
Leads: Dongzhimen Hospital, Beijing

This content was sourced from clinicaltrials.gov