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KMID : 1149220190270030213
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Korean Journal of Oriental Medical Prescription
2019 Volume.27 No. 3 p.213 ~ p.221
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A Comparative Clinical Trial to Evaluate the Efficacy and Safety of 'Hwangryunhaedok-tang' in Treatment of Gastritis : Study Protocol
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Kim Hee-Yeon
Choi Jun-Yong
Cheon Jin-Hong
Kim Kyung-Ho
Kim Kwang-Youn
Oh Tae-Woo
Kim Young-Woo
Park Kwang-Il
Kim Ki-Bong
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Abstract
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Objectives : The purpose of this study is to confirm the efficacy and safety of the treatment of gastritis with 'Hwangryunhaedok-tang‘.
Methods : Total 20 people, between 19 and 65 years old, will be recruited to participate in a comparative clinical trial. All subjects will take 2 capsules of Hwangryunhaedok-tang (Redoxin Cap.), 3 times a day, 30 minutes after meals, for 8 weeks. Outcomes will be measured at the baseline, 4th week, and 8th week. Primary outcomes is the improvement rates of gastritis symptoms, such as heartburn, nausea/vomiting, abdominal bloating, anorexia, heartburn, and trim.
Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2018011), and registered in Clinical Research information Service, one of WHO. Recruitment opened in April 2019 and is supposed to be completed by December 2019.
Conclusions : This trial will provide clinical information to determine the efficacy and safety of treatment of gastritis with 'Hwangryunhaedok-tang‘.
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KEYWORD
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Hwangryunhaedok-tang, gastritis, clinical trial, protocol
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