DyspepsiaNCT02465996
Gastric Barrier Dysfunction of Functional Dyspepsia and Therapeutic Response to Puyuanhewei Detected by Endomicroscopy
A study testing pCLE examination and Puyuanhewei in people with Dyspepsia, run by Shandong University at 1 site in China.
Trial summary
Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be helpful to improve the symptoms of FD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- pCLE examination and Puyuanhewei
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive outpatients aged 18 to 75 years old.
- FD patients defined by the Rome III classification.
- Willing to choose pCLE and no organic diseases.
Who cannot join
- Severe liver, heart, or kidney diseases.
- Current or past evidence of uncontrolled diabetes mellitus, psychosomatic disorders, such as depressive and anxiety disorders, and drug or alcohol abuse.
- Pregnant or breastfeeding women.
- Inability to give informed consent.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD.PhD., 86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn
Yanqing Li, MD. PhD.
About this study
Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be helpful to improve the symptoms of FD.
Read the 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.
- Conditions
- Dyspepsia
- Being tested
- pCLE examination, Puyuanhewei
- Keywords
- barrier dysfunction, functional dyspepsia, Confocal Laser Endomicroscopic, therapeutic response
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pCLE examinationDevice
Also called prob-based confocal laser endomicroscopy examination
All FD patients received pCLE examination.
PuyuanheweiDrug
Also called Puyanhewei capsule administration
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 group | Role | What they receive |
|---|---|---|
| postprandial distress syndrome (PDS) | Other | FD patients fulfilled Rome III criteria were subclassified into postprandial distress syndrome (PDS) or epigastric pain syndrome (EPS).
pCLE examination was performed in PDS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination. Receives: Device: pCLE examination; Drug: Puyuanhewei |
| epigastric pain syndrome (EPS) | Other | pCLE examination was performed in EPS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination. Receives: Device: pCLE examination; Drug: Puyuanhewei |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCLE score
Used to assess the gastric barrier dysfunction of FD patients
Measured: within 1 hour after pCLE examination
Secondary outcomes (2)
Leeds dyspepsia questionaire
Used to describe the change of severity of FD from baseline to the 4th week during the treatment
Measured: baseline and 4th week
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
Measured: baseline and 4th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJul 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465996
- Sponsor's protocol ID
- 2015SDU-QILU-G02
- Status last verified
- Jun 2015
- First submitted
- 1 Jun 2015
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Barrier Dysfunction of Functional Dyspepsia and Therapeutic Response to Puyuanhewei Detected by Endomicroscopy
- ClinicalTrials.gov ID
- NCT02465996
- Acronym / sponsor ID
- 2015SDU-QILU-G02
- Conditions
- Dyspepsia
- Keywords
- barrier dysfunction, functional dyspepsia, Confocal Laser Endomicroscopic, therapeutic response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postprandial distress syndrome (PDS) | Other | Device: pCLE examination, Drug: PuyuanheweiFD patients fulfilled Rome III criteria were subclassified into postprandial distress syndrome (PDS) or epigastric pain syndrome (EPS). pCLE examination was performed in PDS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination. |
| epigastric pain syndrome (EPS) | Other | Device: pCLE examination, Drug: PuyuanheweipCLE examination was performed in EPS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive outpatients aged 18 to 75 years old.
- FD patients defined by the Rome III classification.
- Willing to choose pCLE and no organic diseases.
Key exclusion criteria (5 listed)
- Severe liver, heart, or kidney diseases.
- Current or past evidence of uncontrolled diabetes mellitus, psychosomatic disorders, such as depressive and anxiety disorders, and drug or alcohol abuse.
- Pregnant or breastfeeding women.
- Inability to give informed consent.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pCLE examinationAlso: prob-based confocal laser endomicroscopy examinationAll FD patients received pCLE examination. | Device | epigastric pain syndrome (EPS), postprandial distress syndrome (PDS) |
| PuyuanheweiAlso: Puyanhewei capsule administrationFD patients willing to receive Puyuanhewei were given 4 pills three times a day regardless of PDS or EPS for 4 weeks after pCLE examination. | Drug | epigastric pain syndrome (EPS), postprandial distress syndrome (PDS) |
Primary outcome
pCLE score
Time frame: within 1 hour after pCLE examination
Used to assess the gastric barrier dysfunction of FD patients
2 secondary outcomes
Leeds dyspepsia questionaire
Time frame: baseline and 4th week
Main dyspepsia symptom score
Time frame: baseline and 4th weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqing Li principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pCLE examination and Puyuanhewei in people with Dyspepsia, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li, MD.PhD. (86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCLE score (time frame: within 1 hour after pCLE examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.