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

March 27, 2013 updated by: China Medical University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Recruiting
        • China Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Hsueh Chou Lai, MD
        • Sub-Investigator:
          • Ching Liang Hsieh, PhD
        • Sub-Investigator:
          • Yi Hsiang Shih, MD
        • Sub-Investigator:
          • Yang Yuan Chen
        • Sub-Investigator:
          • Jen Wei Chou
        • Sub-Investigator:
          • Cheng Ju Yu
        • Sub-Investigator:
          • Chun Lung Feng
        • Sub-Investigator:
          • Tsai Chung Li, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Gender:Male or female.
  2. Age: from 20 y/o to 75 y/o.
  3. The diagnosis is Gastroesophageal Reflux Disease.
  4. With the symptoms of heartburn or acid regurgitation.
  5. After explaining thoroughly the whole research purpose or process, the clients are willing to sign the agreement.

Exclusion Criteria:

  1. Exclude peptic ulcer, gall bladder stone (including intraheptaic and common hepatical duct) and major diseased of cancer.
  2. Barrett's esophagus or esophagus stricture.
  3. The operation history of esophagus or gastroduodenoal regions.
  4. Tarry stool suspected GI tract bleeding.
  5. With the history of alcohol or drug abuse.
  6. The clients with the history of study drug allergy.
  7. The clients with psychologic cannot cooperate with each other.
  8. The pregnant woman or the lactating women.
  9. Abnormal liver function such as GOT, GPT elevated over double the normal range.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omeprazole
Omeprazole at a rate of 20mg once per day
Other: Placebo
Experimental: Wu-Chu-Yu Tang
Wu-Chu-Yu Tang at a rate of 3.0 g three times per day
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RDQ Questionnaire
Time Frame: Chang from baseline RDQ score at week 4 (28 ± 5 days)
Chang from baseline RDQ score at week 4 (28 ± 5 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
GerD Questionnaire
Time Frame: Chang from baseline GerD score at week 4 (28 ± 5 days)
Chang from baseline GerD score at week 4 (28 ± 5 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Hsueh Chou Lai, MD, China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

March 24, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

April 2, 2013

Study Record Updates

Last Update Posted (Estimate)

April 2, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH102-REC2-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe