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

Gastroesophageal Reflux Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01822106
• Other study ID #: CMUH102-REC2-011
• Status: Recruiting
• Phase: Phase 4
• First received: March 24, 2013
• Last updated: March 27, 2013
• Start date: February 2013

Study information

• Verified date: March 2013
• Source: China Medical University Hospital
• Contact: Hsueh Chou Lai, MD
• Phone: 886-4-22052121
• Email: D3145[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Other:
• Placebo

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RDQ Questionnaire		Chang from baseline RDQ score at week 4 (28 ± 5 days)	Yes
Secondary	GerD Questionnaire		Chang from baseline GerD score at week 4 (28 ± 5 days)	Yes