Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06348498

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Actively Recruiting

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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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Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure | DecenTrialz