Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspective of Liver and Spleen

NCT04454996 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-07-02

No results posted yet for this study

Summary

To clarify the changes of intestinal flora - gut - brain axis in FGIDs patients represented by NERD disharmony of liver and stomach and IBS-D disharmony of liver and spleen, and confirm that the imbalance between intestinal flora and host co-metabolism is the key to the pathogenesis of functional gastrointestinal disease. To reveal the common mechanism of regulating liver and spleen (stomach) in treating FGIDs dynamic disorder and visceral hypersensitivity by regulating intestinal flora - intestine - brain axis disorder.

Conditions

  • Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome

Interventions

DRUG

tong-jiang granules

This is a kind of compound Chinese medicine granules, 1 bag each time, 3 times a day, treatment for 4 weeks.

DRUG

Chang 'an II Recipe

This is Chang 'an II Prescription granule, 1 bag each time, 3 times a day, treatment for 4 weeks.

DRUG

The placebo of tong-jiang granules

This is a granule, containing 5% tongyu granule active drug,1 bag each time, 3 times a day, treatment for 4 weeks.

DRUG

The placebo of Chang 'an II Recipe

This is a granule containing 5% chang 'an II,1 bag each time, 3 times a day, treatment for 4 weeks.

Sponsors & Collaborators

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2021-09-30
Completion
2022-03-30

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 NCT04454996 on ClinicalTrials.gov