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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02465996
• Other study ID #: 2015SDU-QILU-G02
• Status: Recruiting
• Phase: N/A
• First received: June 1, 2015
• Last updated: June 4, 2015
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Shandong University
• Contact: Yanqing Li, MD.PhD.
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Device:
• pCLE examination
All FD patients received pCLE examination.

Drug:
• Puyuanhewei
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.

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCLE score	Used to assess the gastric barrier dysfunction of FD patients	within 1 hour after pCLE examination	No
Secondary	Leeds dyspepsia questionaire	Used to describe the change of severity of FD from baseline to the 4th week during the treatment	baseline and 4th week	No
Secondary	Main dyspepsia symptom score	Used to describe the change of severity and frequency of despepsia symptoms from baseline to the 4th week during the treatment	baseline and 4th weeks	No