Clinical trial NCT04317339: The Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency
Official title: A Randomized，Double-blinded, Placebo-controlled Trial Evaluating the Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: heart failure with preserved ejection fraction
Qi-Yin deficiency syndrome
randomized, double blinded and controlled trial
Zhigancao Tang granule
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 122
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Comply with the diagnostic criteria of Western medicine for HFpEF and the diagnostic criteria for TCM syndromes of Qi-Yin deficiency;
2. Cardiac function classification by NYHA: grade I to III;
3. Age between 30 and 80 years old;
4. Those who volunteer to participate in clinical trial observation, sign informed consent and indicate date;
5. 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:

1. Valvular heart disease, restrictive cardiomyopathy, pericardial disease;
2. Decompensated heart failure is unstable after treatment;
3. Combined with atrial fibrillation;
4. Patients with severe lung, liver, endocrine system and kidney dysfunction;
5. Patients with cancer and other common malignant diseases reducing life expectancy;
6. Pregnant or lactating women;
7. Allergic constitution or allergic history to common drugs;
8. Patients with mental illness or poor compliance of traditional Chinese medicine treatment.

Primary outcomes:
measure: Cardiac Functional Grading
timeFrame: 12 weeks
Secondary outcomes:
measure: Ultrasonic cardiogram
timeFrame: 12 weeks
measure: 6-min walking test (6mwt)
timeFrame: 12 weeks
measure: Minnesota Heart Failure Quality of Life Scale
timeFrame: 12 weeks
measure: N-terminal pro-B-type natriuretic peptide（NT-proBNP）
timeFrame: 12 weeks
measure: TCM syndrome score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Longhua Hospital
name: Bing Deng, M.D
role: STUDY_DIRECTOR
References:
citation: Zhang N, Zhao Y, Liu Y, Tang N, Zheng W, Mao M, Liu Q, Shen L, Deng B. A double-blinded, placebo-controlled randomized trial evaluating the efficacy and safety of Zhigancao Tang granules for treating HFpEF: study protocol for a randomized controlled trial. Trials. 2021 Apr 20;22(1):293. doi: 10.1186/s13063-021-05232-6.