Placebo-Controlled Double-Blind Study of the Effect of a Combination of Vital Substances Including Standardized Ginseng Extract G115 on Quality of Life

Author(s): Karlberg, J., Lund, B.

Abstract: Placebo-Controlled Double-Blind Study of the Effect of a Combination of Vital Substances Including Standardized Ginseng Extract G115 on Quality of LifeObjective: To determine the effect of a combination of vital substances with standardized ginseng extract G115 on quality of life (QoL) in healthy subjects.Study Design: Double-blind, randomized, placebo-controlled study of 12 weeks duration,Subjects: Healthy, employed volunteers of both sexes older than 25 years. Exclusioncriteria: systolic blood pressure > 200 mm Hg, diastolic blood pressure > 100 mm Hg,sensitivity to ginseng extracts, alcohol and drug abuse, pregnancy, lactation, inability or unwillingness to cooperate, concomitant medication (except short-term medication, e. g. against symptoms like gastro-intestinal discomfort or headache).Intervention: 1 capsule of the G115 combination (n = 205) or placebo (n = 185) twice daily for a period of 12 weeks.Outcome Measures: QoL was evaluated in 2 standard, self-administered questionnaires, the Psychological General Well-Being (PGWB) index and the Sleep Dysfunction scale. In addition to these, a list of 36 bipolar adjectives in visual analogue scales (VAS) was used to quantify changes in other behavioral aspects.Results: 185 subjects taking placebo and 205 taking the combination of active substances completed the study. Both the combination and the placebo group improved their general well-being, but the improvement from baseline was more pronounced in those subjects taking the combination of active substances. According to the VAS scores, subjects receiving the combination improved significantly more in alertness (p = 0.05), relaxation (p = 0.02), appetite (p = 0.04) and overall score (p = 0.03). Among the subjects with the 20% lowest scores at baseline (they were considered as a subgroup), the combination improved both alertness (p=0.03) and depressed mood (p = 0.05).Conclusions: Treatment with a combination of vital substances including standardized ginseng extract G115 may be useful to improve QoL in healthy subjects.

Keyword(s): Ginseng

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