The Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency

• Status: Not yet recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai University of Traditional Chinese Medicine
• Treatments: Adrenergic beta-Antagonists; Diuretics; Mineralocorticoid Receptor Antagonists

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.