Gastric Barrier Dysfunction of Functional Dyspepsia and Therapeutic Response to Puyuanhewei Detected by Endomicroscopy

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02465996

Enrollment

200

Registered

2015-06-09

Start date

2014-07-31

Completion date

2015-06-30

Last updated

2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia

Keywords

barrier dysfunction, functional dyspepsia, Confocal Laser Endomicroscopic, therapeutic response

Brief summary

Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be helpful to improve the symptoms of FD.

Detailed description

This study aimed to investigate the gastric mucosal dysfunction in functional dyspepsia (FD) and verify the efficacy of Puyuanhewei for treating FD and assess the relationship between gastric microalterations and therapeutic response by endomicroscopy.

Interventions

DEVICEpCLE examination

All FD patients received pCLE examination.

DRUGPuyuanhewei

FD patients willing to receive Puyuanhewei were given 4 pills three times a day regardless of PDS or EPS for 4 weeks after pCLE examination.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Consecutive outpatients aged 18 to 75 years old. 2. FD patients defined by the Rome III classification. 3. Willing to choose pCLE and no organic diseases.

Exclusion criteria

1. Severe liver, heart, or kidney diseases. 2. Current or past evidence of uncontrolled diabetes mellitus, psychosomatic disorders, such as depressive and anxiety disorders, and drug or alcohol abuse. 3. Pregnant or breastfeeding women. 4. Inability to give informed consent. 5. Use of nonsteroidal anti-inflammatory drugs, proton pump inhibitors, H2-receptor antagonists, antacids, prokinetics, or other injurious drugs (antibiotics, and steroids) in the prior two weeks.

Design outcomes

Primary

Measure	Time frame	Description
pCLE score	within 1 hour after pCLE examination	Used to assess the gastric barrier dysfunction of FD patients

Secondary

Measure	Time frame	Description
Leeds dyspepsia questionaire	baseline and 4th week	Used to describe the change of severity of FD from baseline to the 4th week during the treatment
Main dyspepsia symptom score	baseline and 4th weeks	Used to describe the change of severity and frequency of despepsia symptoms from baseline to the 4th week during the treatment

Countries

China

Contacts

Primary ContactYanqing Li, MD.PhD.

liyanqing@sdu.edu.cn86-531-82169236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026