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

Study Overview
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Brief Summary
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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
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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