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Efficacy and Safety of Modified Gegen Qinlian Decoction for Diarrhea-predominant Irritable Boewl Syndrome

NCT04312477 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-03-18

No results posted yet for this study

Summary

Diarrhea-predominant irritable boewl syndrome(IBS-D) seriously affect the quality of life in patients. Clinically, it is effective to apply therapeutic method of clearing heat and promoting diuresis to the common syndrome of dampness-heat. Dysbiosis of intestinal microbiota is closely related to the immune imbalance and intestinal mucosal barrier injury. C1orf106/CYTH-1/ARF6 signal pathway, which derive from intestinal micro environment changes,is the mainly cause of intestinal mucosal barrier injury, and this is may be the common pathogenesis of dampness-heat syndrome in IBS-D . Based on the clinic, the project is to study the effect and mechanism of Chinese compound formula of clearing heat and promoting dieresis in modulating intestinal microbiota dysbiosis, repairing intestinal mucosal barrier and reconstructing intestinal microenvironment. With the combination of metagenomics and metabonomics, the study compare the differences of co-metabolites of intestinal microbiota and host within the healthy people, IBS-D patients with dampness-heat syndrome, to explore the relevance between intestinal flora and host co-metabolites. Furthermore, the experimental study is to clarify the drug targets via C1orf106/ CYTH-1/ARF6 signal pathway.Through the study of association between dampness-heat syndrome in IBS-D and intestinal microbiota, it is of important academic significance to reveal the Chinese theory intension of "homotherapy for heteropathy ".

Conditions

  • Diarrhea-predominant Irritable Boewl Syndrome

Interventions

DRUG

Modified Gegen Qinlian Decoction

Modified Gegen Qinlian Decoction contains Pueraria lobata 24g, Scutellaria baicalensis 9g, Coptis chinensis 9g, artillery ginger 9g, talc 9g, roasted licorice 6g, and granules are prepared according to 10:1 production process.

Sponsors & Collaborators

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-04-01
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04312477 on ClinicalTrials.gov