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Efficacy Study and Evaluation System Exploration of Linggui Zhugan Decoction in Intervention on Patients with Heart Failure with Preserved Ejection Fraction (HFpEF) of Yang Deficiency and Water Retention Type from the Perspective of 'Disease-Syndrome Combination

Efficacy Study and Evaluation System Exploration of Linggui Zhugan Decoction in Intervention on Patients with Heart Failure with Preserved Ejection Fraction (HFpEF) of Yang Deficiency and Water Retention Type from the Perspective of 'Disease-Syndrome Combination

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001969
Enrollment
Unknown
Registered
2025-10-22
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Yang Deficiency and Water Retention Type Heart Failure with Preserved Ejection Fraction (HFpEF)

Interventions

Placebo control group:Linggui Zhugan Granule Simulator
Experimental Group:Linggui Zhugan Granules

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Simultaneously meet the diagnostic criteria for Heart Failure with Preserved Ejection Fraction as specified in the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024 and the diagnostic criteria for Yang Deficiency and Water Retention pattern, with cardiac function classification (NYHA Class II-III);(2) Patients aged between 30 and 85 years, regardless of gender;(3) Patients must have follow-up conditions;(4) Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with cardiogenic shock, acute myocardial infarction, severe arrhythmia, severe valvular heart disease, pericardial disease, or those with cardiac assist devices or heart transplantation; (2) Patients with severe comorbidities such as malignant tumors, hyperthyroidism, severe chronic obstructive pulmonary disease (COPD), severe infections, urinary tract infections, or autoimmune diseases; (3) Patients with severe hepatic or renal dysfunction; (4) Pregnant or lactating women; (5) Patients with psychiatric disorders.

Design outcomes

Primary

MeasureTime frame
Kansas City Cardiomyopathy Questionnaire (KCCQ);—

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Score;The 6-Minute Walk Test;New York Heart Association Functional Classification;The Minnesota Living with Heart Failure Questionnaire;Left Ventricular Ejection Fraction;Stroke Volume;E wave to e' prime ratio;Peak Oxygen Uptake;Heart failure readmission rate;—

Countries

China

Contacts

Public ContactChen Xinlin

Longhua Hospital Shanghai University of Traditional Chinese Medicine

heal7374@163.com18917763013

Outcome results

None listed

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