Randomized, Double-Blind Study of Efficacy and Safety of Gynostemma pentaphyllum Ethanol Extract in a Normal Population

정상인에서 스트레스와 불안에 대한 돌외추출물의 효과와 안전성에 관한 무작위 배정 이중 맹검 임상시험

  • Jeong, Seong-Hae (Department of Neurology, Chungnam National University Hospital, Chungnam National University College of Medicine) ;
  • Lee, Myung-Koo (College of Pharmacy and Research Center for Bioresource and Health, Chungbuk National University) ;
  • Park, Mi-Sook (College of Pharmacy and Research Center for Bioresource and Health, Chungbuk National University) ;
  • Kim, Jae-Moon (Department of Neurology, Chungnam National University Hospital, Chungnam National University College of Medicine)
  • 정성해 (충남대학교병원 신경과) ;
  • 이명구 (충북대학교 약학대학 약학과) ;
  • 박미숙 (충북대학교 약학대학 약학과) ;
  • 김재문 (충남대학교병원 신경과)
  • Received : 2011.01.02
  • Accepted : 2011.06.13
  • Published : 2011.06.30

Abstract

The purpose of this study was to evaluate the clinical efficacy of a standardized special ethanol extract from Gynostemma pentaphyllum as a management for anxiety and stress of normal population. This is a two-arm, parallelgroup, randomized, double blind clinical trial comparing Gynostemma pentaphyllum extract 200 mg bid (GP-EX, n=48) or placebo bid (n=54). The main outcome measures were the decrease in anxiety sensitivity index (ASI), the State version (S-STAI) of the Stait-Trait Anxiety Inventory (STAI) and the Trait version (T-STAT) of the STAI from baseline over a 6 weeks treatment period. In more anxious group (S-STAI50 or ASI19), the anxiety in group with GP-EX was decreased significantly than one in normal population with placebo [S-STAI50: T-STAI = from $57.7{\pm}6.5$ ($mean{\pm}S.D.$) to $46.8{\pm}11.2$ in normal population with GP-EX, p=0.002 vs. from $54.1{\pm}9.9$ to $49.0{\pm}9.6$ in normal population with placebo, p>0.05; ASI19: T-STAI = from $47.2{\pm}12.0$ to $42.4{\pm}11.1$ in normal population with GP-EX, p=0.022 vs. from $48.7{\pm}11.5$ to $46.0{\pm}10.4$ in normal population with placebo, p>0.05]. The most frequently reported adverse reactions considered possibly related to treatment were mild gastrointestinal events. GP-EX is more effective than placebo and is well tolerated as a therapy for anxiety and stress of normal population.

Keywords

Gynostemma pentaphyllum;anti-anxiety;anti-stress;ASI;S-STAI;T-STAI

Acknowledgement

Supported by : 생물건강산업개발연구센터,(주)명성바이오텍

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