Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Wu-Chu-Yu Tang on Gastroesophageal Reflux Disease (GERD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 2014|
Active Comparator: Omeprazole
Omeprazole at a rate of 20mg once per day
Experimental: Wu-Chu-Yu Tang
Wu-Chu-Yu Tang at a rate of 3.0 g three times per day
- RDQ Questionnaire [ Time Frame: Chang from baseline RDQ score at week 4 (28 ± 5 days) ]
- GerD Questionnaire [ Time Frame: Chang from baseline GerD score at week 4 (28 ± 5 days) ]
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
|Contact: Hsueh Chou Lai, MD||886-4-22052121 ext 7635||D3145@mail.cmuh.org.tw|
|China Medical University Hospital||Recruiting|
|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|
|Principal Investigator:||Hsueh Chou Lai, MD||China Medical University Hospital|