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

June 26, 2020 updated by: Xiyuan Hospital of China Academy of Chinese Medical Sciences
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100091
        • Recruiting
        • Digestive department of Xi Yuan Hospital of China Academy of Chinese Medical Sciences
        • Contact:
          • Lv Lin, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The treatment group
The subjects in this group were treated with Xiangsha Liujunzi granule for 4 weeks
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SF-36 scale
Time Frame: 4 weeks
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)
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZZ13-YQ-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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