Effective Mechanisms of Wu-Chu-Yu Tang on Gastroesophageal Disorder

NCT04118647 | Unknown Phase 4

• 1 other identifier: CMUH108-REC2-101
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Wu-Chu-Yu Tang; Gastroesophageal Reflux Disorder; 24 Hours Esophageal PH and Multichannel Intraluminal Impedance Testing

Outcome Measures

Primary Outcomes (2)

• 24 hours esophageal PH

  Analysis the 24 hours PH change

  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.

  28 days

Secondary Outcomes (2)

• Reflux Disease Questionnaire

  56 days

• SF-36 questionnaire

  56 days

Study Arms (1)

Wu-Chu-Yu tang

EXPERIMENTAL

Drug: Wu-Chu-Yu tang

Interventions

Wu-Chu-Yu tang DRUG

Wu-Chu-Yu tang at a rate of 3.0 g three times per day for 28 days.

Wu-Chu-Yu tang

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, North District, 40447, Taiwan

RECRUITING

Central Study Contacts

Ching-Liang Hsieh, Ph.D

CONTACT

+886-4-22053366; clhsieh@mail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 8, 2019
• Study Start: October 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 8, 2019

Record last verified: 2019-10

Locations

TW (1)