The Role of Intestinal Flora in the Pathogenesis of FD and the Intervention of Xiangsha Liujunzi

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-07

Study Completion Date

2022-08-30

Brief Summary

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Functional dyspepsia (FD) is a common digestive system disease in clinic. Although it has not reached the level of life-threatening, it seriously affects the quality of life of patients. The pathogenesis of FD mainly involves gastric motility disorder and visceral hypersensitivity. At present, there are gastric motility promoting drugs and gastric acid inhibiting drugs, but they can not achieve satisfactory therapeutic effect. Traditional Chinese medicine has a good clinical effect on FD, but the specific mechanism is not clear. With the gradual deepening of intestinal flora research, it provides a useful tool for elucidating the mechanism of action of traditional Chinese medicine compound. The role of intestinal flora in the pathogenesis of FD, especially in the pathogenesis of symptoms, has not been studied, and the mechanism of Spleen-strengthening and motility-promoting effects of Xiangsha Liujun has not been studied from the perspective of intestinal flora. In this study, 16S rRNA high-throughput sequencing technology was used to observe the difference of intestinal flora between FD patients and normal people, and then to observe the effect of Xiangsha Liujun on intestinal flora of FD patients. The aim of this study was to explore the role of intestinal flora in the pathogenesis of FD and to elucidate the therapeutic mechanism of Xiangsha Liujunzi by regulating intestinal flora of FD patients, so as to provide support for follow-up clinical and experimental studies.

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Detailed Description

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Conditions

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Functional Dyspepsia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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The treatment group

The subjects in this group were treated with Xiangsha Liujunzi granule for 4 weeks

Group Type EXPERIMENTAL

Xiangsha Liujunzi granules

Intervention Type DRUG

A traditional Chinese medicine compound, taken three times a day, one bag at a time, for a total of 28 days

Interventions

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Xiangsha Liujunzi granules

A traditional Chinese medicine compound, taken three times a day, one bag at a time, for a total of 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of functional dyspepsia by Rome IV . ② Clinical diagnosis of spleen deficiency and qi stagnation by CTM. ③ Must be able to swallow potion.

Exclusion Criteria

* Gastric ulcer

* Duodenal ulcer.

* Gastroesophageal reflux disease .

* Chronic gastritis with HP (+).

* Chronic pancreatitis.

* Diabetes.

* Chronic renal insufficiency.

* Hematological disease.

* tumor or AIDS.

* Pregnant or lactating women.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes