The Role of Intestinal Flora in the Pathogenesis of FD and the Intervention of Xiangsha Liujunzi
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- General impression scale
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
The treatment group
The subjects in this group were treated with Xiangsha Liujunzi granule for 4 weeks
Intervention: Xiangsha Liujunzi granules (Drug)
Outcomes
Primary Outcomes
General impression scale
Time Frame: 4 weeks
Significant deterioration, slight deterioration, no remission, slight remission,significant remission, complete remission.Change from baseline on different levels at 4 weeks.
Symptom severity scale
Time Frame: 4 weeks
early satiety,upper abdominal pain, postprandial fullness discomfort,Burning sensation of upper abdomen.Change from baseline on symptom severity scale at 4 weeks.
Secondary Outcomes
- SF-36 scale(4 weeks)
- TCM symptom score (TCMSS)(4 weeks)