Evidence map›Paper›PMID 33879223›Full record

ArticleTrials2021

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.

Na Zhang, Yingli Zhao, Yu Liu, Nuo Tang, Wang Zheng, Meijiao Mao, Qingcheng Liu, Lin Shen, Bing Deng

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04317339 (A Randomized，Double-blinded, Placebo-controlled Trial Evaluating the Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04317339 phase2unknown statusnot on this map

A Randomized，Double-blinded, Placebo-controlled Trial Evaluating the Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency

TypeinterventionalSponsorShanghai University of Traditional Chinese MedicineRan2020 to 2022Enrolled122ConditionsHeart Failure With Preserved Ejection FractionArmsZhigancao Tang granule, Zhigancao Tang placebo granule
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Na Zhang *Department of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Yingli Zhao *Department of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Yu LiuDepartment of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Nuo TangDepartment of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Wang ZhengDepartment of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Meijiao MaoDepartment of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Qingcheng LiuDepartment of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Lin ShenDepartment of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China. cathylin927@126.com.
Bing DengDepartment of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China. dengbing82@sina.com.
Longhua Hospital Shanghai University of Traditional Chinese Medicine · CNShanghai University of Traditional Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHeart failure with preserved ejection fraction (HFpEF) is a clinical syndrome characterized by diastolic dysfunction. Despite the increasing incidence of HFpEF, there is no available therapy that reduces the mortality rate of HFpEF. Zhigancao Tang has been used traditionally for the treatment of cardiovascular diseases in China. The use of traditional Chinese medicine (TCM) is associated with improvements in clinical syndromes and quality of life of patients. A randomized clinical trial should be conducted to provide clear evidence regarding the efficacy and safety of Zhigancao Tang granules for the treatment of HFpEF.

methodsA randomized, double-blinded, placebo-controlled clinical trial was proposed. A total of 122 patients with HFpEF will be randomly assigned to receive Zhigancao Tang granules or placebo for 12 weeks. The primary outcome measure is cardiac function. The secondary outcomes include measurement of the integral TCM syndrome score, echocardiography, 6-min walk test, N-terminal-pro hormone B-type natriuretic peptide level, atrial natriuretic peptide level, Minnesota Living with Heart Failure scale, and Lee's scale. The outcome measures will be evaluated at baseline, 4 weeks, and 12 weeks. Adverse events will be evaluated from baseline till the 12-week follow-up period. DISCUSSION: The results of this trial will demonstrate whether Zhigancao Tang granules are effective and safe for treating HFpEF.

trial registrationClinicalTrials.gov NCT04317339 . Registered on 23 March 2020.

Indexed as

Heart FailureChinaDouble-Blind MethodHumansMinnesotaQuality of LifeRandomized Controlled Trials as TopicStroke VolumeTreatment OutcomeHeart failure with preserved ejection fractionRandomized controlled trialTraditional Chinese medicineZhigancao Tang

Identifiers

PMID33879223
PMCPMC8056488
OpenAlexW3153246636

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.