Status:
UNKNOWN
The Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency
Lead Sponsor:
Shanghai University of Traditional Chinese Medicine
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
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 HF...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04317339
Start Date
March 20 2020
End Date
March 31 2022
Last Update
March 23 2020
Active Locations (1)
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1
Longhua Hospital
Shanghai, Shanghai Municipality, China, 200032