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Clinical study of Wenyang Huoxue Lishui plaster in the treatment of chronic heart failure

Early Phase 1
Not yet recruiting
Conditions
Chronic heart failure
Registration Number
ITMCTR2023000034
Lead Sponsor
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) aged between 18 and 80 years old;
(2) meet the diagnostic criteria for stable chronic heart failure;
(3) New York Heart Association (NYHA) functional class II-III;
(4) patients with reduced ejection fraction (LVEF < 40%);
(5) The syndrome of Yang qi deficiency and blood stasis combined with phlegm and drink;
(6) Lee's heart failure score =6;
(7) The subjects had fully informed consent to participate in this study voluntarily, and signed the informed consent form by themselves.

Exclusion Criteria

(1) Heart failure due to kidney, liver and other important organ failure;
(2) Patients with severe heart failure or grade IV heart function were not included in the study.
(3) presence of various malignant tumors or suspicious malignant tumors;
(4) history of thrombotic disease within 6 months;
(5) patients with obvious liver and kidney diseases or ALT and AST higher than ULN 1.5 times, creatinine and urea nitrogen higher than ULN 1.5 times;
(6) patients with severe mental disorders, hematopoietic system diseases and other major diseases;
(7) women who are pregnant, lactating or have a positive pregnancy test, or have plans to give birth within a certain period of time;
(8) patients with redness, swelling, ulceration or skin diseases;
(9) have participated or are participating in other clinical investigators within the past three months;
(10) suspected or definite allergy to study drugs;
(11) Factors that increase mortality: Patients with cardiogenic shock, severe ventricular arrhythmia, complete atrioventricular block, obstructive cardiomyopathy, unpatched valvular disease, constrictive pericarditis, pericardial tamponade, pulmonary embolism, obvious infection, uncontrolled hypertension, acute myocarditis, acute coronary syndrome, and chronic heart failure requiring device therapy were excluded.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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