Browse > Article
http://dx.doi.org/10.14374/HFS.2019.27.3.213

A Comparative Clinical Trial to Evaluate the Efficacy and Safety of 'Hwangryunhaedok-tang' in Treatment of Gastritis : Study Protocol  

Kim, Hee-Yeon (Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital)
Choi, Jun-Yong (Department of Korean Internal Medicine, Pusan National University Korean Medicine Hospital)
Cheon, Jin-Hong (Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital)
Kim, Kyung ho (Korean Medicine Application Center, Korea Institute of Oriental Medicine)
Kim, Kwang-Youn (Korean Medicine Application Center, Korea Institute of Oriental Medicine)
Oh, Tae-woo (Korean Medicine Application Center, Korea Institute of Oriental Medicine)
Kim, Young woo (College of Korean Medicine, Dongguk University)
Park, Kwang Il (Korean Medicine Application Center, Korea Institute of Oriental Medicine)
Kim, Kibong (Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital)
Publication Information
Herbal Formula Science / v.27, no.3, 2019 , pp. 213-221 More about this Journal
Abstract
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'.
Keywords
Hwangryunhaedok-tang; gastritis; clinical trial; protocol;
Citations & Related Records
Times Cited By KSCI : 7  (Citation Analysis)
연도 인용수 순위
1 Park HK, Kim N, Lee SW, Park JJ, Kim JI, Lee SY, et al., The Distribution of Endoscopic Gastritis in 25,536 Heath Check-up Subjects in Korea. Korean J Helicobacter Up Gastrointest Res. 2012;12(4): 237-43.   DOI
2 Kim MH, Choi MG, Rew JS, Seol SY. Phase 3 Clinical Trial of Stillen(TM) for Erosive Gastritis. Korean J Gastrointest Endosc. 2004;28(5):230-6.
3 Vakil N. Peptic ulcer disease. In: Mark F, Lawrence F, Lawrence B. Sleisenger and Fordtran's gastrointestinal and liver disease: pathophysiology, diagnosis, management. 10th ed. Philadelphia:Elsevier. 2016:861-4.
4 Choi MG, Park SH, Kim SK, Chang R, Choi SR, Song GA, et al., Phase III Clinical Trial of Revaprazan (Revanex(R)) for Gastritis. Korean J Gastrointest Endosc. 2006;33(4):212-9.
5 Zendehdel N, Nasseri-Moghaddam S, Malekzadeh R, Massarrat S, Sotoudeh M, Siavoshi F. Helicobacter pylori reinfection rate 3 years after successful eradication. J Gastroenterol Hepatol. 2005;20(3):401-4.   DOI
6 Fang JY, Liu WZ, Li ZS, Du YQ, Ji XL, Ge ZZ, Li YQ, Si JM, Lu NH, Wu KC, Chen Y, Xiao SD. Consensus on standard management of choronic gastritis in China. Chinese J Gastroenterology. 2013;18(01):24-36.
7 Zhang WD, Li JX, Chen ZS, Wei BH, Dong TX. Comprehensive agreement on diagnosis and treatment of chronic gastritis with integrated traditional chinese and western medicine(Tianjin, 2011). Chinese Journal of Integrated Traditional and Western Medicine. 2012;32(06):738-43.
8 Im DH, Yun JY, Jang SI, Yun YG. Effect of Hwangyeonhaedok-tang on Experimental Mouse Colitis Induced by Dextran Sulfate Sodium. Herbal Formula Science. 2011:19(2);11-22.   DOI
9 요양급여의 적용기준 및 방법에 관한 세부사항. Available from: URL: www.mohw.go.kr/react/jb/sjb0406vw.jsp?PAR_MENU_ID=03&MENU_ID=030406&CONT_SEQ=320797&page=1
10 Kim BA, Kim MS, Kang BM, Byeon SH, Park IH, Park JH, et al., Inhibitory Studies of Hwangryunhaedok-tang on Development of Atopic Dermatitis in NC/Nga Mice. Korea J Herbology. 2008:23(2);59-65.
11 Kim IS, Seo JJ, Kim KG, Ha DR, Shin MK, Kim ES, et al., Antimicrobial Activity of Hwangryunhaedok-tang Extract against Keratitis. Korean J Intern Med. 2014;35(3):288-97.
12 Kim HY, Hong SH, Park IH, Shin SH, Kwon YM. Twenty-two Case of Acne Treated by Hwangryunhaedok-tang Pharmacopuncture Therapy Combined with Herbal Medicine and Extrusion. J Korean Med Ophthalmol Otolaryngol Dermatol. 2015;28(3):114-25.   DOI
13 Ohta Y, Kobayashi T, Nishida K, Sasaki E, Ishiguro I. Preventive effect of Oren-gedoku-to (Huanglian-Jie-Du-Tang) extract on the development of stress-induced acute gastric mucosal lesions in rats. J Ethnopharmacol. 1999;67(3):377-84.   DOI
14 Lee HW, Kang SH, Park GE, Lee KH, Hong YS, Lee K, et al., Survey on the Endoscopic Diagnosis of Chronic Gastritis. Korean J Helicobacter Up Gastrointest Res. 2014;14(3):194-8.   DOI
15 Lee HL. The Classification and Diagnosis of Gastritis. The 51st Seminar of Korean Society of Gastrointestinal Endoscopy. 2014
16 Cheung DY. Endoscopic Findings of Acute Gastritis. The Classification and Diagnosis of Gastritis. The 53rd Seminar of Korean Society of Gastrointestinal Endoscopy. 2015
17 Kim YB. Chronic gastritis. Korean J Med. 2001;61(2):221-3.
18 Lee SY. Endoscopic gastritis, serum pepsinogen assay, and Helicobacter pylori infection. Korean J Intern Med. 2016;31(5): 835-44.   DOI
19 Yoon SY, Shim KN. Indications for Helicobacter pylori Eradication Therapy. Korean J Helicobacter Up Gastrointest Res. 2012;12(4):213-8.   DOI
20 Ko MJ, Baek JH. A Clinical study on the effect of hwangryunhaedock-tang on atopic dermatitis. J Pediatr Korean Med. 2012;26(4):51-60.   DOI
21 Choi YY, Kim MH, Lee TH, Yang WM. Evaluation of efficacy evaluation of hwangryunhaedok-tang and gungangbuja- tang on lipopolysaccharide (LPS)-induced inflammation mouse model. Herbal Formula Science 2012;20(2):83-92.   DOI
22 Mizukawa H, Yoshida K, Honmura A, Uchiyama Y, Kaku H, Nakajima S, Haruki E. The effect of oregedokuto on experimentallyinflamed rats. American J Chinese Med. 1993;21:71-78.   DOI
23 Chen M, Liao Z, Lu B, Wang M, Lin L, Zhang S, et al., Huang-Lian-Jie-Du- Decoction Ameliorates Hyperglycemia and Insulin Resistant in Association With Gut Microbiota Modulation. Front Microbiol. 2018; 9:2380.   DOI
24 Chen G, Lu FE, Jin D, Xu LJ, Wang KF. Effect of huanglian jiedu decoction ) on glucose transporter 4 expression in adipose and skeletal muscle tissues of insulin resistant rats. Chin J Integr Med. 2007; 13(1):41-5.   DOI
25 Ding LB, Lu FE, Ye AL, Xu L, Wang K. Effects of huanglian jiedu decoction on leptin and resistin in insulin resistive rats. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2006;26(3):232-5.
26 위염 치료제 임상시험 가이드라인. Available from: URL: http://www.nifds.go.kr/brd/m_15/view.do?seq=8956&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=52
27 Choi YY, Kim MH, Lee TH, Yang WM. Evaluation of Efficacy evaluation of Hwangryunhaedok-tang and Gungangbuja -tang on lipopolysaccharide (LPS)-induced inflammation mouse model. Herbal formula science. 2012;20(2):83-92.   DOI
28 Yang HJ, Joo HA, Back SC, Park JS, Hong SH. Anti-inflammatory effects of Hwangnyeonhaedok -tang and Fermented Hwangnyeonhaedok-tang. J Korean Med Ophthalmol Otolaryngol Dermatol. 2011;24(2):1-15.   DOI
29 Kim HK, Hong SU. The anti-inflammatory effects of Huang-Lyun (Coptidis Rhizoma, CR) on injured tissue after burn elicitation. J Korean Oriental Med 2011;32(2):1-13.
30 DI Kim, HJ Cheong, SK Cheong, HK Lee. The Inhibitory Effects of Schizandrae Fructus and Coptidis Rhizoma on the IL-6, IL-16, GM-CSF MRNA level of BEAS-2B Human Epithelial Cells. J Kyung Hee Univ Med Cent. 2001;17(2):199-213.
31 Lee HW, Kang SH, Park GE, Lee KH, Hong YS, Lee K, et al., Survey on the Endoscopic Diagnosis of Chronic Gastritis. Korean J Helicobacter Up Gastrointest Res. 2014;14(3):194-8.   DOI