Effective Mechanisms of Wu-Chu-Yu Tang on Gastroesophageal Disorder
Primary Purpose
Wu-Chu-Yu Tang, Gastroesophageal Reflux Disorder, 24 Hours Esophageal PH and Multichannel Intraluminal Impedance Testing
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Wu-Chu-Yu tang
Sponsored by
About this trial
This is an interventional treatment trial for Wu-Chu-Yu Tang
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- China Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wu-Chu-Yu tang
Arm Description
Outcomes
Primary Outcome Measures
24 hours esophageal PH
Analysis the 24 hours PH change
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04118647
First Posted
September 18, 2019
Last Updated
October 4, 2019
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04118647
Brief Title
Effective Mechanisms of Wu-Chu-Yu Tang on Gastroesophageal Disorder
Official Title
Effective Mechanisms of Wu-Chu-Yu Tang on Gastroesophageal Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wu-Chu-Yu Tang, Gastroesophageal Reflux Disorder, 24 Hours Esophageal PH and Multichannel Intraluminal Impedance Testing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wu-Chu-Yu tang
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Wu-Chu-Yu tang
Intervention Description
Wu-Chu-Yu tang at a rate of 3.0 g three times per day for 28 days.
Primary Outcome Measure Information:
Title
24 hours esophageal PH
Description
Analysis the 24 hours PH change
Time Frame
28 days
Title
DeMeester score
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Reflux Disease Questionnaire
Description
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.
Time Frame
56 days
Title
SF-36 questionnaire
Description
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.
Time Frame
56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Liang Hsieh, Ph.D
Phone
+886-4-22053366
Ext
3127
Email
clhsieh@mail.cmuh.org.tw
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
State/Province
North District
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Liang Hsieh, Ph.D
Phone
+886-4-22053366
Ext
3127
Email
clhsieh@mail.cmuh.org.tw
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effective Mechanisms of Wu-Chu-Yu Tang on Gastroesophageal Disorder
We'll reach out to this number within 24 hrs