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

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04449887
• Other study ID #: ZZ13-YQ-006
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: June 2020
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: Lv Lin, Doctor
• Phone: 010-62835641
• Email: lushangshitou[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 30, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of functional dyspepsia by Rome IV . ? Clinical diagnosis of spleen deficiency and qi stagnation by CTM. ? 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.

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Drug:
• Xiangsha Liujunzi granules
A traditional Chinese medicine compound, taken three times a day, one bag at a time, for a total of 28 days

Locations

Country	Name	City	State
China	Digestive department of Xi Yuan Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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