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

NCT04449887 | Unknown

• 1 other identifier: ZZ13-YQ-006
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia

Keywords

xiangshaliujunzi,functional dyspepsia，Intestinal flora

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• SF-36 scale

  4 weeks

• TCM symptom score (TCMSS)

  4 weeks

Study Arms (1)

The treatment group

EXPERIMENTAL

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

Drug: Xiangsha Liujunzi granules

Interventions

Xiangsha Liujunzi granules DRUG

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

The treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Digestive department of Xi Yuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

RECRUITING

Central Study Contacts

Lv Lin, Doctor

CONTACT

010-62835641; lushangshitou@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 29, 2020
• Study Start: July 7, 2020
• Primary Completion: December 1, 2021
• Study Completion: August 30, 2022
• Last Updated: June 29, 2020

Record last verified: 2020-06

Locations

CN (1)