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

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Functional Dyspepsia

Treatments: Drug: Xiangsha Liujunzi granules

Study type: Interventional

Funder types: Other

Identifiers

NCT04449887

ZZ13-YQ-006

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

The treatment group

Experimental group

Description:

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

Treatment:

Drug: Xiangsha Liujunzi granules