Evidence map›Paper›PMID 33143731›Full record

ArticleTrials2020

Efficacy of Tong-Xie-Yao-Fang granule and its impact on whole transcriptome profiling in diarrhea-predominant irritable bowel syndrome patients: study protocol for a randomized controlled trial.

Yan Wang, Yong-Quan Huang, Shui-Lian Zhu, Chang-Rong Zhang, Xin-Lin Chen, Qiu-Ke Hou, Feng-Bin Liu

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
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  4. Article
  5. 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

7 authors at 3 institutions in 2 countries.

Yan WangDepartment of Gastroenterology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Yong-Quan HuangDepartment of Orthopedics, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Shui-Lian ZhuDepartment of Gastroenterology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Chang-Rong ZhangDepartment of Gastroenterology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Xin-Lin ChenDepartment of Preventive Medicine and Health Statistics, Guangzhou University of Chinese Medicine, Guangzhou, China.
Qiu-Ke HouDepartment of Gastroenterology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. houqiuke@gzucm.edu.cn.
Feng-Bin LiuDepartment of Gastroenterology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. liufb163@126.com.ORCID http://orcid.org/0000-0002-8957-9260
First Affiliated Hospital of Guangzhou University of Chinese Medicine · CNGuangzhou University of Chinese Medicine · CNHong Kong Baptist University · HK

Funding

Guangdong Provincial Traditional Chinese Medicine Research Project 20181095Innovative Research Team Project of "Innovative Strong Institute", the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine 2017TD05key research projects of first-class disciplines of Guangzhou University of Chinese Medicine -National Natural Science Foundation of China 81774264National Natural Science Foundation of China 81804047
6 · The paper itself

Abstract

backgroundIrritable bowel syndrome (IBS) is one kind of common functional bowel disease with obscure pathogenesis, and exploration about whole transcriptome profiling in IBS-D is still negligible. Conventional medications have limited effects, which makes focus shifted to traditional Chinese medicine (TCM). Tong-Xie-Yao-Fang, as a classic herbal formula in TCM, is pretty effective and safe for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), but the underlying therapeutic mechanism remains unknown. We aim to verify the efficacy and safety of TXYF granule (the formula particles mixed together) in IBS-D and elucidate the gene-level mechanism of IBS-D and therapeutic targets of TXYF granule based on whole transcriptome analysis. METHODS/

designThis is a randomized, double-blind, and placebo-controlled clinical trial consisting of 2 weeks of run-in period, 12 weeks of treatment period, and 8 weeks of follow-up period. We will enroll 120 participants with IBS-D, who will be randomly assigned to the TXYF granule group and the placebo group, and recruit additional 10 healthy individuals as controls for mechanistic outcome. The two groups respectively take TXYF granule or placebo orally for treatment. The primary outcome is the response rate of IBS-Symptom Severity Score (IBS-SSS). The secondary outcomes include adequate relief (AR), IBS-Quality of Life Questionnaire (IBS-QOL), and long-term efficacy. Mechanistic outcome is the whole transcriptome profiling of the intestinal mucosae from IBS participants before and after the treatment and healthy individuals. DISCUSSION: This trial will prove the effectiveness and safety of TXYF granule with high-quality evidence and provide a penetrating and comprehensive perspective on the molecular mechanism of IBS-D by whole transcriptome analysis, which makes us pinpoint specific biomarkers of IBS-D and therapeutic targets of TXYF.

trial registrationChinese Clinical Trial Registry ChiCTR-IOR-1900021785 . Registered on 9 March 2019.

Indexed as

Drugs, Chinese HerbalIrritable Bowel SyndromeDiarrheaDouble-Blind MethodGene Expression ProfilingHumansQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeDrugs, Chinese HerbalDiarrhea-predominant irritable bowel syndromeRandomized controlled trialTong-Xie-Yao-Fang granuleTraditional Chinese medicineWhole transcriptome profiling

Identifiers

PMID33143731
PMCPMC7607547
OpenAlexW3095929420

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.