Clinical trial NCT04118647: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Wu-Chu-Yu Tang
Gastroesophageal Reflux Disorder
24 Hours Esophageal PH and Multichannel Intraluminal Impedance Testing
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Gender：male or female.
2. Age：from 20 years old (inclusive) to 75 years old (inclusive).
3. Diagnosis of gastroesophageal reflux disease.
4. there is a heartburn or acid regurgitation phenomenon.
5. After detailed description of the entire research purpose or process, voluntarily participate in the study and sign the consent form.

Exclusion Criteria:

1. Exclude peptic ulcers, gallstones (including intrahepatic and common bile ducts) and major diseases such as: cancer, congestive hear failured NYHA class\>II, COPD attack.
2. Barrett's esophagus, narrow esophagus or caustic injury of upper gastrointestinal tract.
3. History of esophagus and gastroduodenal surgery.
4. Tarry stool suspected gastrointestinal bleeding.
5. History of alcohol or drug abuse.
6. Patients with a history of allergies to the test drug.
7. Can not cooperate with mental illness.
8. Pregnant women or women who are breastfeeding.
9. Liver function SGOT and SGPT are more than twice the normal value.
10. renal function test BUN, Creatinine is greater than the normal value.

Primary outcomes:
measure: 24 hours esophageal PH
timeFrame: 28 days
measure: DeMeester score
timeFrame: 28 days
Secondary outcomes:
measure: Reflux Disease Questionnaire
timeFrame: 56 days
measure: SF-36 questionnaire
timeFrame: 56 days
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: North District
Study officials:
References: