The Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency
HFpEF
A Randomized，Double-blinded, Placebo-controlled Trial Evaluating the Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency
1 other identifier
interventional
122
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2020
CompletedStudy Start
First participant enrolled
March 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedMarch 23, 2020
November 1, 2019
2 years
March 4, 2020
March 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiac Functional Grading
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.
12 weeks
Secondary Outcomes (5)
Ultrasonic cardiogram
12 weeks
6-min walking test (6mwt)
12 weeks
Minnesota Heart Failure Quality of Life Scale
12 weeks
N-terminal pro-B-type natriuretic peptide（NT-proBNP）
12 weeks
TCM syndrome score
12 weeks
Study Arms (2)
Zhigancao Tang granule group
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Longhua Hospital
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
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.
PMID: 33879223DERIVED
Study Officials
- STUDY DIRECTOR
Bing Deng, M.D
Shanghai Longhua Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2020
First Posted
March 23, 2020
Study Start
March 20, 2020
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
March 23, 2020
Record last verified: 2019-11