The Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency
NCT ID: NCT04317339
Last Updated: 2020-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
122 participants
INTERVENTIONAL
2020-03-20
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Zhigancao Tang granule group
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 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.
Zhigancao Tang placebo group
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
80 Years
ALL
No
Sponsors
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Shanghai University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Bing Deng, M.D
Role: STUDY_DIRECTOR
Shanghai Longhua Hospital
Locations
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Longhua Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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ZGCT
Identifier Type: -
Identifier Source: org_study_id
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