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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2023000034
Enrollment
Unknown
Registered
2023-08-24
Start date
2023-08-31
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure

Interventions

Control group:On the basis of conventional western medicine treatment, heart failure plaster placebo was used (The placebo did not contain the original drug ingredients)

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Lee's score for heart failure;

Secondary

MeasureTime frame
Minnesota Quality of Life in Heart Failure Questionnaire;Left Ventricular Ejection Fraction;NYHA cardiac function classification;24-hour urine output;Efficacy evaluation of TCM syndromes;N-Terminal Pro-Brain Natriuretic Peptide;

Countries

China

Contacts

Public ContactRuina Bai

Xiyuan Hospital, China Academy of Chinese Medical Sciences

brntcl@126.com152 1097 5077

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026