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Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Wu-Chu-Yu Tang on Gastroesophageal Reflux Disease (GERD)

NCT01822106 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2013-04-02

No results posted yet for this study

Summary

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.

Although proton pump inhibitor (PPI) can inhibit gastric acid secretion, relief symptom and enhancing repair of esophageal damage, therefore, PPI is a main drug for the treatment of GRED, but because of PPI has disadvantage of poor compliance, and slow gastric empty time and hypersensitivity, and about 40-50% of GERD patients is inefficacy. In addition, PPI produces bone fracture, community pneumonia and diarrhea in patient with long-term use.

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.

Therefore, the purpose of the present study was to investigate the efficacy of Wu-Chu-Yu tang on GRED, and this effect of Wu-Chu-Yu tang compared to PPI Omeprazole.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

OTHER

Placebo

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Hsueh Chou Lai, MD · China Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01822106 on ClinicalTrials.gov