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Randomized, Double-Blind Study of Efficacy and Safety of Gynostemmapentaphyllum Ethanol Extract in a Normal Population
Korean J Clin Pharm 2011;21(2):131-137
Published online June 30, 2011
© 2011 Korean College of Clinical Pharmacy.

Seong-Hae Jeong, Myung Koo Leeb, Mi Sook Park, and Jae-Moon Kim

Department of Neurology, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon Korea, College of Pharmacy and Research Center for Bioresource and Health, Chungbuk National University, Cheongju, Korea
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 ± 6.5 (mean ± S.D.) to 46.8 ± 11.2 in normal population with GP-EX, p=0.002 vs. from 54.1 ± 9.9 to 49.0 ± 9.6 in normal population with placebo, p>0.05; ASI19: T-STAI = from 47.2 ± 12.0 to 42.4 ± 11.1 in normal population with GP-EX, p=0.022 vs. from 48.7 ± 11.5 to 46.0 ± 10.4 in normal population with placebo, p>0.05]. The most frequently reportedadverse reactions considered possibly related to treatment were mild gastrointestinal events. GP-EX is more effectivethan 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.


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