A Randomized，Double-blinded, Placebo-controlled Trial Evaluating the Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency
Overview
- Phase
- Phase 2
- Intervention
- Zhigancao Tang granule
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Sponsor
- Shanghai University of Traditional Chinese Medicine
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Cardiac Functional Grading
- Last Updated
- 6 years ago
Overview
Brief Summary
This study was designed as a randomized, double blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the efficacy and safety of Zhigancao Tang granule in patients with HFpEF of Qi-Yin dificiency.
Detailed Description
Heart failure with preserved ejection fraction (HFPEF) is a clinical syndrome characterized by diastolic dysfunction.The incidence of HFpEF is increasing in recent years. Standard treatment of heart failure does not improve the prognosis of HFPEF patients. Zhigancao Tang was used to improve the symptoms of chronic heart failure in China.This randomized,double-blinded and placebo-controlled trial will objectively and standardly evaluate the effectiveness and safety of Zhigancao Tang granule.After 12 weeks of treatment, 122 HFpEF patients with deficiency of Qi and Yin were observed and evaluated in terms of heart function, clinical symptoms,exercise tolerance and quality of life.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Comply with the diagnostic criteria of Western medicine for HFpEF and the diagnostic criteria for TCM syndromes of Qi-Yin deficiency;
- •Cardiac function classification by NYHA: grade I to III;
- •Age between 30 and 80 years old;
- •Those who volunteer to participate in clinical trial observation, sign informed consent and indicate date;
- •During the observation period, those who do not take other drugs other than those specified and can insist on completing the treatment and observation.
Exclusion Criteria
- •Valvular heart disease, restrictive cardiomyopathy, pericardial disease;
- •Decompensated heart failure is unstable after treatment;
- •Combined with atrial fibrillation;
- •Patients with severe lung, liver, endocrine system and kidney dysfunction;
- •Patients with cancer and other common malignant diseases reducing life expectancy;
- •Pregnant or lactating women;
- •Allergic constitution or allergic history to common drugs;
- •Patients with mental illness or poor compliance of traditional Chinese medicine treatment.
Arms & Interventions
Zhigancao Tang granule group
Participants in experimental group will receive Zhigancao Tang granule therapy for 12 weeks. In addition, participants will receive standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters, diuretics as needed.
Intervention: Zhigancao Tang granule
Zhigancao Tang placebo group
Participants in experimental group will receive Zhigancao Tang placebo granule therapy for 12 weeks. In addition, participants will receive standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed.
Intervention: Zhigancao Tang placebo granule
Outcomes
Primary Outcomes
Cardiac Functional Grading
Time Frame: 12 weeks
Significant effect: cardiac function recovered to level 1 or increased by level 2; Effective: cardiac function increased by level 1 but failed to reach level 2; Ineffective: cardiac function did not change; Worsening: cardiac function decreased by level 1 or above.
Secondary Outcomes
- TCM syndrome score(12 weeks)
- Ultrasonic cardiogram(12 weeks)
- 6-min walking test (6mwt)(12 weeks)
- N-terminal pro-B-type natriuretic peptide（NT-proBNP）(12 weeks)
- Minnesota Heart Failure Quality of Life Scale(12 weeks)