search
Back to results

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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Omeprazole

Wu-Chu-Yu Tang

Arm Description

Omeprazole at a rate of 20mg once per day

Wu-Chu-Yu Tang at a rate of 3.0 g three times per day

Outcomes

Primary Outcome Measures

RDQ Questionnaire

Secondary Outcome Measures

GerD Questionnaire

Full Information

First Posted
March 24, 2013
Last Updated
March 27, 2013
Sponsor
China Medical University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01822106
Brief Title
Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Wu-Chu-Yu Tang on Gastroesophageal Reflux Disease (GERD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omeprazole
Arm Type
Active Comparator
Arm Description
Omeprazole at a rate of 20mg once per day
Arm Title
Wu-Chu-Yu Tang
Arm Type
Experimental
Arm Description
Wu-Chu-Yu Tang at a rate of 3.0 g three times per day
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
RDQ Questionnaire
Time Frame
Chang from baseline RDQ score at week 4 (28 ± 5 days)
Secondary Outcome Measure Information:
Title
GerD Questionnaire
Time Frame
Chang from baseline GerD score at week 4 (28 ± 5 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 y/o to 75 y/o. The diagnosis is Gastroesophageal Reflux Disease. With the symptoms of heartburn or acid regurgitation. After explaining thoroughly the whole research purpose or process, the clients are willing to sign the agreement. Exclusion Criteria: Exclude peptic ulcer, gall bladder stone (including intraheptaic and common hepatical duct) and major diseased of cancer. Barrett's esophagus or esophagus stricture. The operation history of esophagus or gastroduodenoal regions. Tarry stool suspected GI tract bleeding. With the history of alcohol or drug abuse. The clients with the history of study drug allergy. The clients with psychologic cannot cooperate with each other. The pregnant woman or the lactating women. Abnormal liver function such as GOT, GPT elevated over double the normal range.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsueh Chou Lai, MD
Phone
886-4-22052121
Ext
7635
Email
D3145@mail.cmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsueh Chou Lai, MD
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsueh Chou Lai, MD
Phone
886-4-22052121
Ext
7635
Email
D3145@mail.cmuh.org.tw
First Name & Middle Initial & Last Name & Degree
Hsueh Chou Lai, MD
First Name & Middle Initial & Last Name & Degree
Ching Liang Hsieh, PhD
First Name & Middle Initial & Last Name & Degree
Yi Hsiang Shih, MD
First Name & Middle Initial & Last Name & Degree
Yang Yuan Chen
First Name & Middle Initial & Last Name & Degree
Jen Wei Chou
First Name & Middle Initial & Last Name & Degree
Cheng Ju Yu
First Name & Middle Initial & Last Name & Degree
Chun Lung Feng
First Name & Middle Initial & Last Name & Degree
Tsai Chung Li, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs