Actively Recruiting
Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2024-06-28
18
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure.
CONDITIONS
Official Title
Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years, either sex
- Diagnosed with coronary heart disease and chronic heart failure
- Meet traditional Chinese medicine criteria for Yang deficiency and blood stasis in chronic heart failure
- Left ventricular ejection fraction (LVEF) less than 40% by Modified Simpson's Method
- New York Heart Association (NYHA) functional class II to III
- On a stable dose of standard chronic heart failure medication for at least 2 weeks
- Understand study requirements and provide written informed consent
You will not qualify if you...
- Acute heart failure or acute worsening of chronic heart failure
- Heart failure caused by other heart diseases such as congenital heart disease, severe valve disease, cardiomyopathies, pericardial diseases, or infective endocarditis
- Acute coronary syndrome within 30 days before trial drug or major cardiac procedures within 6 months prior
- Planned implantable device or cardiovascular surgery during the trial
- Severe arrhythmias or conduction blocks without pacemaker
- Serious diseases in other systems including liver, kidney, blood, tumors, or mental illness
- Uncontrolled high blood pressure or low blood pressure
- Liver enzymes ALT or AST more than 3 times normal or severely reduced kidney function
- High blood sugar or anemia
- Elevated blood potassium
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- History of drug abuse with positive drug tests
- Women who are pregnant, nursing, or planning pregnancy within 3 months after last dose
- Participation in other clinical trials with investigational drugs within 3 months prior
- Allergy to Jia Shen Tablets or their ingredients
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
R
Rui Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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