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A Randomized Controlled Trial on the Improvement of Cardiac Function Classification in Heart Failure Patients with Yang Deficiency and Blood Stasis Type by Linggui Yangxin Decoction

A Randomized Controlled Trial on the Improvement of Cardiac Function Classification in Heart Failure Patients with Yang Deficiency and Blood Stasis Type by Linggui Yangxin Decoction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000556
Enrollment
Unknown
Registered
2026-03-18
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Chronic heart failure

Interventions

Experimental Group:Standardized treatment for chronic heart failure + Linggui Yangxin Decoction granules
Control Group:Standardized treatment for chronic heart failure + placebo granules

Sponsors

The First People's Hospital of Yunnan Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients must meet all the following criteria to be eligible for this study: 1) Aged 18-85 years, regardless of gender; 2) History of chronic heart failure for over 1 month or clinical findings of heart failure symptoms for over 1 month. Chronic heart failure diagnosis refers to the 'Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024'; 3) NYHA cardiac function classification II-III; 4) Traditional Chinese Medicine (TCM) syndrome differentiation of Yang deficiency and blood stasis, based on the 'Guidelines for TCM Diagnosis and Treatment of Chronic Heart Failure (2022)'; 5) Voluntary participation with informed consent signed;

Exclusion criteria

Exclusion criteria: 1) Patients who received implantable cardioverter defibrillator or cardiac resynchronization therapy within 12 weeks; 2) Complicated with acute coronary syndrome (within 30 days), cardiogenic shock, acute myocarditis, uncontrolled malignant arrhythmia, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, severe valvular disease requiring surgery, or pulmonary embolism; 3) Comorbidities including severe primary diseases of heart, liver, kidney, hematopoietic or metabolic systems, malignancies, jaundice, or hepatic/renal insufficiency; 4) Complicated with acute infections; 5) Uncontrolled hypertension (systolic blood pressure =180mmHg or diastolic blood pressure =110mmHg); 6) HIV antibody-positive, syphilis-positive, hepatitis B or C patients; 7) Worsening heart failure symptoms due to digitalis toxicity; 8) Women planning pregnancy, pregnant, or lactating; 9) Suspected or confirmed alcohol/drug abusers; 10) Allergic constitution or known/suspected allergy to study drugs; 11) Received other investigational drugs within 60 days prior to randomization; 12) Patients deemed by investigators as unable to complete or comply with study requirements (due to administrative or other reasons).

Design outcomes

Primary

MeasureTime frame
NYHA cardiac function classification;

Secondary

MeasureTime frame
N-terminal pro-B-type natriuretic peptide (NT-proBNP);TCM syndrome score;Echocardiogram;Minnesota Heart Failure Quality of Life Assessment;6-minute walk test;

Countries

China

Contacts

Public ContactZhang Hong

The First People's Hospital of Yunnan Province

zhanghong@kust.edu.cn13888250238

Outcome results

None listed

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