This trial will assess the efficacy and safety of QSG in CHF.
Drug: Qishen Granules
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Locations near you
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Full eligibility criteria for NCT03027375
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
age between 18 and 75 years;
clinical findings of CHF for at least 3 months prior to screening;
CHF caused by coronary heart disease and hypertension, which is diagnosed according to the Chinese guidelines published in 2014 for the diagnosis and management of CHF;
clinically stable condition with an NYHA functional class of II to III and an optimal medical treatment with a fixed dosage for at least 2 weeks;
a documented left ventricular ejection fraction (LVEF) ≤40% and a serum NT-proBNP level ≥450 pg/ml;
CHF of Qi deficiency and blood stasis syndrome;
provision of written informed consent.
CHF complicated with severe valvular disease, congenital heart disease, pericardial disease, cardiomyopathy, unstable angina, acute myocardial infarction(in recent 4 weeks), cardiogenic shock, acute myocarditis, infective endocarditis, uncontrolled severe cardiac arrhythmia with hemodynamic changes;
pulmonary heart disease, pulmonary hypertension caused by acute or chronic pulmonary embolism or cerebral apoplexy in recent 6 months;
severe hepatic inadequacy with alanine aminotransferase or alkaline phosphatase levels
>2 times the upper normal limit, renal inadequacy with a creatinine clearance rate＞20% or a serum creatinine level＞3mg/dl (＞265μmol/L), severe electrolyte imbalance, severe hematologic disease, malignant tumor, diabetes mellitus with severe complications, or severe endocrine diseases such as hyperthyroidism and hypothyroidism;
acute infection confirmed by any one of the following 3 tips: 1) fever; 2) a white blood cell count＞10×109/L and a percentage of neutrophils＞85%; 3) shadows on chest X-ray;
uncontrolled blood pressure or fibrosis in other organs;
CHF of yin deficiency according to TCM syndrome differentiation;
pregnancy or breastfeeding;
psychiatric or infectious disease;
patients who have participated in other clinical trials in the past two months.
All locations for NCT03027375
China-Japan Friendship Hospital
Beijing, Beijing, China, 100029
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View full eligibility
Tris trial is registered with FDA with number: NCT03027375. The sponsor of the trial is Beijing University of Chinese Medicine and it is looking for 200 volunteers for the current phase.
Official trial title: Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure: Study Protocol for a Randomized Controlled Trial
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