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

Primary Purpose

Functional Dyspepsia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Xiangsha Liujunzi granules
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Functional Dyspepsia focused on measuring xiangshaliujunzi,functional dyspepsia,Intestinal flora

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Digestive department of Xi Yuan Hospital of China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The treatment group

Arm Description

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

Outcomes

Primary Outcome Measures

General impression scale
Significant deterioration, slight deterioration, no remission, slight remission,significant remission, complete remission.Change from baseline on different levels at 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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 6, 2020
Last Updated
June 26, 2020
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04449887
Brief Title
The Role of Intestinal Flora in the Pathogenesis of FD and the Intervention of Xiangsha Liujunzi
Official Title
The Role of Intestinal Flora in the Pathogenesis of FD and the Intervention of Xiangsha Liujunzi
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 7, 2020 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
xiangshaliujunzi,functional dyspepsia,Intestinal flora

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The treatment group
Arm Type
Experimental
Arm Description
The subjects in this group were treated with Xiangsha Liujunzi granule for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Xiangsha Liujunzi granules
Intervention Description
A traditional Chinese medicine compound, taken three times a day, one bag at a time, for a total of 28 days
Primary Outcome Measure Information:
Title
General impression scale
Description
Significant deterioration, slight deterioration, no remission, slight remission,significant remission, complete remission.Change from baseline on different levels at 4 weeks.
Time Frame
4 weeks
Title
Symptom severity scale
Description
early satiety,upper abdominal pain, postprandial fullness discomfort,Burning sensation of upper abdomen.Change from baseline on symptom severity scale at 4 weeks.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
SF-36 scale
Description
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.
Time Frame
4 weeks
Title
TCM symptom score (TCMSS)
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lv Lin, Doctor
Phone
010-62835641
Email
lushangshitou@qq.com
Facility Information:
Facility Name
Digestive department of Xi Yuan Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lv Lin, Doctor

12. IPD Sharing Statement

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

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