Trial | NCT04317339  Report issue

Title

The Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency
A Randomized，Double-blinded, Placebo-controlled Trial Evaluating the Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    122
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.
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.
Study Started
Mar 20
2020
Anticipated
Primary Completion
Mar 31
2022
Anticipated
Study Completion
Mar 31
2022
Anticipated
Last Update
Mar 23
2020

Drug Zhigancao Tang granule

Zhigancao Tang: Dissolve Zhigancao Tang granule in 200ml hot water, twice a day,12 weeks, oral. Standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed.

  • Other names: Zhigancao Tang group, Zhigancao Tang granule group

Drug Zhigancao Tang placebo granule

Zhigancao Tang placebo: Dissolve Zhigancao Tang placebo granule in 200ml hot water, twice a day,12 weeks, oral. Standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed.

  • Other names: Zhigancao Tang placebo group, Zhigancao Tang placebo granule group

Zhigancao Tang granule group Experimental

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.

Zhigancao Tang placebo group Placebo Comparator

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.

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.
No Results Posted