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

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ClinicalTrials.gov Identifier: NCT01822106
Recruitment Status : Unknown
Verified March 2013 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : April 2, 2013
Last Update Posted : April 2, 2013
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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.


Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2013
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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



Primary Outcome Measures :
  1. RDQ Questionnaire [ Time Frame: Chang from baseline RDQ score at week 4 (28 ± 5 days) ]

Secondary Outcome Measures :
  1. GerD Questionnaire [ Time Frame: Chang from baseline GerD score at week 4 (28 ± 5 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822106


Contacts
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Contact: Hsueh Chou Lai, MD 886-4-22052121 ext 7635 D3145@mail.cmuh.org.tw

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Hsueh Chou Lai, MD    886-4-22052121 ext 7635    D3145@mail.cmuh.org.tw   
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         
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Hsueh Chou Lai, MD China Medical University Hospital

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01822106     History of Changes
Other Study ID Numbers: CMUH102-REC2-011
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: April 2, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases