| Randomized, Double-blind, Placebo-controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Artemisia and Green Tea Extract SD1003F in Volunteers with Helicobacter pylori-associated Gastric Discomfort |
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Sang Oh Kwon, Dong Yun Kwak, Sung Pyo Hong, Won Hee Kim, Jong Min Park, Young Min Han, You Kang, Eun A Kang, Seohyun Jo, Ki Baik Hahm |
1S&D Food Research Center, Cheongwon, Korea.
2Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea. hahmkb@cha.ac.kr
3CHA Cancer Prevention Research Center, Seongnam, Korea. |
| 인진쑥과 녹차 추출물 복합물인 SD1003F의 Helicobacter pylori 연관 기능성 위장장애 지원자에 대한 유효성 및 안전성 평가를 위한 무작위 배정, 이중 맹검, 위약대조 임상시험 |
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권상오1, 곽동윤1, 홍성표2, 김원희2, 박종민3, 한영민3, 강 유3, 강은아3, 조서현2, 함기백2,3 |
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S&D 기업부설연구소1, CHA 의과학대학교 분당차병원 소화기센터2, CHA Bio Complex 차 암예방 연구센터3 |
Correspondence:
Ki Baik Hahm, Tel: +82-31-881-7178, Fax: +82-31-881-7185,
Email: hahmkb@cha.ac.kr
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Received: 29 August 2017 • Revised: 31 October 2017 • Accepted: 9 November 2017 |
| Abstract |
BACKGROUND/AIMS
A previous study showed that dietary intervention with Artemisia and green tea extracts, i.e., SD1003F, relieved Helicobacter pylori-associated chronic atrophic gastritis in a mouse model. We continue the research through the current randomized double-blind clinical trial to evaluate the efficacy and safety of the intervention for H. pylori-associated gastric discomfort. MATERIALS AND METHODS: Forty-nine volunteers who tested positive for H. pylori infection received either placebo or SD1003F for 10 weeks and their functional dyspepsia-related quality of life (QOL) was evaluated. H. pylori infection using a urea breath test (UBT), measurement of pepsinogen level using GastroPanel. Adverse effects with biochemical changes were also evaluated. RESULTS: SD1003F administration significantly improved health related-QOL, including dietary intake, emotional stability, life pattern, and social factors relevant to gastric discomfort, in comparison to the control (P < 0.05). The mean UBT measurement significantly decreased in the SD1003F group (P < 0.05). In 2 of the 24 volunteers, SD1003F alone eradicated H. pylori infection, with significant improvements in endoscopic findings. GastroPanel analysis revealed significant improvements that reflect rejuvenation of gastric atrophy in the SD1003F group. No significant side effect was observed in any participant. CONCLUSIONS: SD1003F (Artemisia and green tea extract), is a potential phytochemical to improve H. pylori-associated gastric discomfort. |
| Key Words:
Artemisia; Atrophy; Functional dyspepsia; Green tea; Helicobacter pylori |
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