Evidence map›Paper›PMID 35655286›Full record

ArticleTrials2022

Zhizhu Kuanzhong Capsule in treating patients with functional dyspepsia postprandial distress syndrome: study protocol for a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial.

Mengli Xiao, Linda L D Zhong, Wai Ching Lam, Yingpan Zhao, Kok-Ann Gwee, Gerald Holtmann, Jan Tack, Hidekazu Suzuki, Min-Hu Chen, Yinglian Xiao and 5 more

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

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03825692 (A Multi-center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Trial of Zhizhu Kuanzhong Capsule in Treating Patients With Postprandial Distress Syndrome of Functional Dyspepsia), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 38% 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.

NCT03825692 phase4unknown statusnot on this map

A Multi-center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Trial of Zhizhu Kuanzhong Capsule in Treating Patients With Postprandial Distress Syndrome of Functional Dyspepsia

TypeinterventionalSponsorXiyuan Hospital of China Academy of Chinese Medical SciencesRan2019 to 2023Enrolled480ConditionsFunctional Dyspepsia, Postprandial Distress SyndromeArmsZhizhu Kuanzhong Capsule, Zhizhu Kuanzhong Placebo Capsule
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Combinatorial chemistry & high throughput screening · 2026
    Article
  3. Article
  4. Article
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

15 authors at 8 institutions in 5 countries.

Mengli Xiao *NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine and National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Linda L D Zhong *School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.ORCID http://orcid.org/0000-0002-3877-1914
Wai Ching LamSchool of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Yingpan ZhaoDepartment of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China.
Kok-Ann GweeDepartment of Medicine, Yong Loo Lin School of Medicine, National University of Singapore and Gleneagles Hospital, Singapore, Singapore.
Gerald HoltmannFaculty of Medicine & Faculty of Health & Behavioural Sciences, University of Queensland, Brisbane, QLD, Australia.
Jan TackDepartment of Gastroenterology, University Hospitals Leuven, Leuven, Belgium.
Hidekazu SuzukiDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa, Japan.
Min-Hu ChenDivision of Gastroenterology and Hepatology, The First Affiliated Hospital, Sun Yatsen University, Guangzhou, Guangdong, China.
Yinglian XiaoDivision of Gastroenterology and Hepatology, The First Affiliated Hospital, Sun Yatsen University, Guangzhou, Guangdong, China.
Xiaohua HouDivision of Gastroenterology, Wuhan Union Hospital, Huazhong Science & Technology University, Wuhan, Hubei, China.
Jinsong LiuDivision of Gastroenterology, Wuhan Union Hospital, Huazhong Science & Technology University, Wuhan, Hubei, China.
Yang LiCenter for Applied Statistics and School of Statistics, Renmin University of China, Beijing, China.
Xu-Dong TangDepartment of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China. txdly@sina.com.
Fang LuNMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine and National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China. deerfang@126.com.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNHong Kong Baptist University · HKSun Yat-sen University · CNWuhan Union Hospital · CNNational University of Singapore · SGRenmin University of China · CNThe University of Queensland · AUTokai University · JP

Funding

special research on modernization of traditional chinese medicine in the national key research and development program in china's 13th five-year plan demonstrative research on tcm-related international cooperation with countries along the belt and road 2017YFC1703703
6 · The paper itself

Abstract

backgroundFunctional dyspepsia (FD) is one of the most common functional gastrointestinal disorders. Based on the various symptoms present in patients with functional dyspepsia postprandial distress syndrome (FD-PDS), routine agents such as acid suppressants, prokinetic drugs, and centrally acting drugs, offer limited treatment choices with potential side effects. As a preliminary clinical trial showed that the marketed product Zhizhu Kuanzhong Capsule (ZZKZ) can improve symptoms in FD-PDS patients, our study aims to provide further evidence on the clinical efficacy and safety of ZZKZ in the treatment of patients with FD-PDS.

methodsIn this multicenter, randomized, patient- and investigator-blinded, placebo-controlled, parallel-group clinical trial, we will recruit patients with FD-PDS from 18 hospitals in China and Australia. The trial will enroll patients with FD-PDS based on the Rome IV diagnostic criteria. A total of 480 eligible patients will be randomized 1:1 into either ZZKZ or placebo group with 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint will be measured by a self-rated Visual Analogue Score (VAS) for the degree of discomfort with both symptoms of postprandial fullness and early satiation, recorded once a day and 7 days a week. The primary analysis will aim to compare the response rate for FD-PDS VAS score between the groups before and after 8 weeks of treatment with an alpha level of 0.05 (2-sided). DISCUSSION: This trial aims to strengthen the evidence for the efficacy and safety of ZZKZ, a marketed product, in treating FD-PDS. Compared to the previous clinical trial that targeted FD-PDS, this trial will have an 8-week double-blind treatment period to investigate the effect of long-term mediation through comparison with the placebo group.

trial registrationClinicalTrials.gov NCT03825692 . Registered on 28 January 2019.

Indexed as

DyspepsiaGastrointestinal DiseasesStomach DiseasesDouble-Blind MethodHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeFunctional dyspepsiaPostprandial distress syndromeRandomized controlled trialZhizhu Kuanzhong

Identifiers

PMID35655286
PMCPMC9161179
OpenAlexW4281775288

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.