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

NCT01822106 | Unknown Phase 4

• 1 other identifier: CMUH102-REC2-011
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• RDQ Questionnaire

  Chang from baseline RDQ score at week 4 (28 ± 5 days)

Secondary Outcomes (1)

• GerD Questionnaire

  Chang from baseline GerD score at week 4 (28 ± 5 days)

Study Arms (2)

Omeprazole

ACTIVE COMPARATOR

Omeprazole at a rate of 20mg once per day

Other: Placebo

Wu-Chu-Yu Tang

EXPERIMENTAL

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

Other: Placebo

Interventions

Placebo OTHER

Omeprazole; Wu-Chu-Yu Tang

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Hsueh Chou Lai, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsueh Chou Lai, MD

CONTACT

886-4-22052121; D3145@mail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2013
• First Posted: April 2, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: April 2, 2013

Record last verified: 2013-03

Locations

TW (1)