Unknown

Dataset Information

0

Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial.


ABSTRACT: Background:Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks. Methods:We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit. Results:In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group. Conclusion:The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.

SUBMITTER: Song SW 

PROVIDER: S-EPMC6190494 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

altmetric image

Publications

Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial.

Song Sang-Wook SW   Kim Ha-Na HN   Shim Jae-Yong JY   Yoo Byeong-Yeon BY   Kim Dae-Hyun DH   Lee Sang-Hyun SH   Park Joo-Sung JS   Kim Moon-Jong MJ   Yoo Jun-Hyun JH   Cho BeLong B   Kang Hee-Cheol HC   Kim Kwang-Min KM   Kim Sung-Soo SS   Kim Kyung-Soo KS  

Journal of ginseng research 20180724 4


<h4>Background</h4>Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks.<h4>Methods</h4>We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG o  ...[more]

Similar Datasets

| S-EPMC7790881 | biostudies-literature
| S-EPMC6823766 | biostudies-literature
| S-EPMC9270655 | biostudies-literature
| S-EPMC6606819 | biostudies-literature
| S-EPMC10720486 | biostudies-literature
| S-EPMC10222860 | biostudies-literature
| S-EPMC9292215 | biostudies-literature
| S-EPMC4875922 | biostudies-literature
| S-EPMC3297520 | biostudies-literature
| S-EPMC3524425 | biostudies-literature