Wu-Chu-Yu TangPhase 4NCT04118647
Effective Mechanisms of Wu-Chu-Yu Tang on Gastroesophageal Disorder
A Phase 4 study testing Wu-Chu-Yu tang in people with Wu-Chu-Yu Tang and Gastroesophageal Reflux Disorder, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Gastroesophageal reflux disorder (GERD) is due to gastric content reflux to esophagus cause symptom and complication including intra-esophagus such as reflux esophagitis, and extra-esophagus such as cough etc. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Wu-Chu-Yu Tang, Gastroesophageal Reflux Disorder, 24 Hours Esophageal PH and Multichannel Intraluminal Impedance Testing
- What is being tested?
- Wu-Chu-Yu tang
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2019to Sep 2021
- Phase
- Phase 4
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender：male or female.
- Age：from 20 years old (inclusive) to 75 years old (inclusive).
- Diagnosis of gastroesophageal reflux disease.
- there is a heartburn or acid regurgitation phenomenon.
- After detailed description of the entire research purpose or process, voluntarily participate in the study and sign the consent form.
Who cannot join
- Exclude peptic ulcers, gallstones (including intrahepatic and common bile ducts) and major diseases such as: cancer, congestive hear failured NYHA class>II, COPD attack.
- Barrett's esophagus, narrow esophagus or caustic injury of upper gastrointestinal tract.
- History of esophagus and gastroduodenal surgery.
- Tarry stool suspected gastrointestinal bleeding.
- History of alcohol or drug abuse.
- Patients with a history of allergies to the test drug.
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- Can not cooperate with mental illness.
- Pregnant women or women who are breastfeeding.
- Liver function SGOT and SGPT are more than twice the normal value.
- renal function test BUN, Creatinine is greater than the normal value.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, North District, 40447
Ching-Liang Hsieh, Ph.D, +886-4-22053366 ext. 3127, clhsieh@mail.cmuh.org.tw
About this study
Gastroesophageal reflux disorder (GERD) is due to gastric content reflux to esophagus cause symptom and complication including intra-esophagus such as reflux esophagitis, and extra-esophagus such as cough etc. Because the changes of dietary habit, and improvement of examination skill and data analysis, the prevalence of GERD increased 2.5 multiple from 1995 to 2002, and suggesting the prevalence is 25% in Taiwan community.
The etiology of GERD is multi-effect, such as transient lower esophageal sphincter relaxation and abnormal pressure of lower esophageal sphincter, which may induced the esophageal mucosal injury by gastric acid, bile or pancreases enzyme.
Wu-Chu-Yu tang consists of Evodia fargesii Dode (Evodia Fruit), Panax ginseng C. (Ginseng), Ziziphus jujube Mill (Chinses Date), Zingiber officinale Rosee (Fresh Ginger).According to "I-Fang-Chi-Chieh" and "Shanghonzobinglun" recordings that Wu-Chu-Yu tang can treat vomiting, and also can relax gastric tonicity and can enhance peristalsis of stomach. According to Randomized, double blind, placebo control trial to evaluate the efficacy of Wu-Chu-Yu Tang on gastroesophageal reflux disease, we know the Wu-Chu-Yu tang have the equivalent effect proton pump inhibitor omeprazole. But, the mechanism of Wu-Chu-Yu tang is still unknown.
- Conditions
- Wu-Chu-Yu Tang, Gastroesophageal Reflux Disorder, 24 Hours Esophageal PH and Multichannel Intraluminal Impedance Testing
- Being tested
- Wu-Chu-Yu tang
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wu-Chu-Yu tangDrug
Wu-Chu-Yu tang at a rate of 3.0 g three times per day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Wu-Chu-Yu tang | Experimental | Not described Receives: Drug: Wu-Chu-Yu tang |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours esophageal PH
Analysis the 24 hours PH change
Measured: 28 days
DeMeester score
DeMeester score had two major component as 1.total time of pH<4(%) and 2.number of reflux episode. Each major part had two minor component.Fist one, percentage of total time pH<4, had 1. percentage of upright time when pH<4 and 2.percentage of supine time when pH<4. Secondary part, number of reflux episode, had 1.number of reflux episode over 5 mintues and 2.longest reflux time. Finally, there was a composite score as the DeMeester score.
Measured: 28 days
Secondary outcomes (2)
Reflux Disease Questionnaire
Reflux Disease Questionnaire had one major component as Thinking about your symptoms over the past 7 days, how often have you had the following? And then there were six minor component: a. A burning feeling behind your breastbone b. Pain behind your breastbone c. A burning feeling in the centre of the upper stomach d. Pain in the centre of the upper stomach e. An acid taste in your mouth f. Unpleasant movement ofmaterial upwards from the stomach. Each question was different frequency as have not had, 1 day, 2 days, 3-4 days, 5-6 days or daily in one week.
Each frequency had one score and subscale had score from one to six. The total score was one to thirty six. The score more less means more better outcome.
Measured: 56 days
SF-36 questionnaire
The scores of each question are added together to obtain the scale. The total score, the higher the total score, the quality of healthy life The higher.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study startOct 2019 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wu-Chu-Yu TangStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118647
- Sponsor's protocol ID
- CMUH108-REC2-101
- Status last verified
- Oct 2019
- First submitted
- 18 Sep 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Mechanisms of Wu-Chu-Yu Tang on Gastroesophageal Disorder
- ClinicalTrials.gov ID
- NCT04118647
- Acronym / sponsor ID
- CMUH108-REC2-101
- Conditions
- Wu-Chu-Yu Tang, Gastroesophageal Reflux Disorder, 24 Hours Esophageal PH and Multichannel Intraluminal Impedance Testing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 8 Oct 2019 (actual)
- 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.
Gastroesophageal reflux disorder (GERD) is due to gastric content reflux to esophagus cause symptom and complication including intra-esophagus such as reflux esophagitis, and extra-esophagus such as cough etc. Because the changes of dietary habit, and improvement of examination skill and data analysis, the prevalence of GERD increased 2.5 multiple from 1995 to 2002, and suggesting the prevalence is 25% in Taiwan community.
The etiology of GERD is multi-effect, such as transient lower esophageal sphincter relaxation and abnormal pressure of lower esophageal sphincter, which may induced the esophageal mucosal injury by gastric acid, bile or pancreases enzyme.
Wu-Chu-Yu tang consists of Evodia fargesii Dode (Evodia Fruit), Panax ginseng C. (Ginseng), Ziziphus jujube Mill (Chinses Date), Zingiber officinale Rosee (Fresh Ginger).According to "I-Fang-Chi-Chieh" and "Shanghonzobinglun" recordings that Wu-Chu-Yu tang can treat vomiting, and also can relax gastric tonicity and can enhance peristalsis of stomach. According to Randomized, double blind, placebo control trial to evaluate the efficacy of Wu-Chu-Yu Tang on gastroesophageal reflux disease, we know the Wu-Chu-Yu tang have the equivalent effect proton pump inhibitor omeprazole. But, the mechanism of Wu-Chu-Yu tang is still unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wu-Chu-Yu tang | Experimental | Drug: Wu-Chu-Yu tang |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gender：male or female.
- Age：from 20 years old (inclusive) to 75 years old (inclusive).
- Diagnosis of gastroesophageal reflux disease.
- there is a heartburn or acid regurgitation phenomenon.
- After detailed description of the entire research purpose or process, voluntarily participate in the study and sign the consent form.
Key exclusion criteria (10 listed)
- Exclude peptic ulcers, gallstones (including intrahepatic and common bile ducts) and major diseases such as: cancer, congestive hear failured NYHA class>II, COPD attack.
- Barrett's esophagus, narrow esophagus or caustic injury of upper gastrointestinal tract.
- History of esophagus and gastroduodenal surgery.
- Tarry stool suspected gastrointestinal bleeding.
- History of alcohol or drug abuse.
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 |
|---|---|---|
| Wu-Chu-Yu tangWu-Chu-Yu tang at a rate of 3.0 g three times per day for 28 days. | Drug | Wu-Chu-Yu tang |
Primary outcome
24 hours esophageal PH
Time frame: 28 days
Analysis the 24 hours PH change
DeMeester score
Time frame: 28 days
DeMeester score had two major component as 1.total time of pH<4(%) and 2.number of reflux episode. Each major part had two minor component.Fist one, percentage of total time pH<4, had 1. percentage of upright time when pH<4 and 2.percentage of supine time when pH<4. Secondary part, number of reflux episode, had 1.number of reflux episode over 5 mintues and 2.longest reflux time. Finally, there was a composite score as the DeMeester score.
2 secondary outcomes
Reflux Disease Questionnaire
Time frame: 56 days
SF-36 questionnaire
Time frame: 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Wu-Chu-Yu tang in people with Wu-Chu-Yu Tang and Gastroesophageal Reflux Disorder, run by China Medical University Hospital at 1 site in Taiwan.
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 5 inclusion and 10 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 8 Oct 2019. 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ching-Liang Hsieh, Ph.D (+886-4-22053366 ext. 3127, clhsieh@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hours esophageal PH (time frame: 28 days). The study lists 2 primary outcomes in all. 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 8 Oct 2019.