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

Study Overview
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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.

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

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Drug: Xiangsha Liujunzi granules


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The treatment group<br>The subjects in this group were treated with Xiangsha Liujunzi granule for 4 weeks | Drug: Xiangsha Liujunzi granules<br>* A traditional Chinese medicine compound, taken three times a day, one bag at a time, for a total of 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General impression scale | Significant deterioration, slight deterioration, no remission, slight remission,significant remission, complete remission.Change from baseline on different levels at 4 weeks. | 4 weeks | 
| Symptom severity scale | early satiety,upper abdominal pain, postprandial fullness discomfort,Burning sensation of upper abdomen.Change from baseline on symptom severity scale at 4 weeks. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 scale | Eight dimensions: physiological function, social function, physiological function, physical pain, mental health, emotional function, vitality, overall health.Change from baseline on every dimension at 4 weeks. | 4 weeks | 
| TCM symptom score (TCMSS) | 15 items: fullness of ruffles, epigastralgia, stupor, heartburn or burning sensation, belching and acid regurgitation, salivation clearing, pharyngeal obstruction, thirsty but not willing to drink water, less abdominal distention and pain, weakness of limbs, shortness of breath, laziness, heavy sleepiness of the whole body and limbs, fear of cold and cold, loose stools.Change from baseline on TCM symptom score (TCMSS) at 4 weeks. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xiangshaliujunzi,functional dyspepsia，Intestinal flora