A Randomized，Double-blinded, Placebo-controlled Trial Evaluating the Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Cardiac Functional Grading
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Zhigancao Tang granule (Drug)
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.
干预措施: Zhigancao Tang placebo granule (Drug)
结局指标
主要结局
Cardiac Functional Grading
时间窗: 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.
次要结局
- 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)