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Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial
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 i...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6190494/ https://www.ncbi.nlm.nih.gov/pubmed/30337818 http://dx.doi.org/10.1016/j.jgr.2018.07.002 |
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author | Song, Sang-Wook Kim, Ha-Na Shim, Jae-Yong Yoo, Byeong-Yeon Kim, Dae-Hyun Lee, Sang-Hyun Park, Joo-Sung Kim, Moon-Jong Yoo, Jun-Hyun Cho, BeLong Kang, Hee-Cheol Kim, Kwang-Min Kim, Sung-Soo Kim, Kyung-Soo |
author_facet | Song, Sang-Wook Kim, Ha-Na Shim, Jae-Yong Yoo, Byeong-Yeon Kim, Dae-Hyun Lee, Sang-Hyun Park, Joo-Sung Kim, Moon-Jong Yoo, Jun-Hyun Cho, BeLong Kang, Hee-Cheol Kim, Kwang-Min Kim, Sung-Soo Kim, Kyung-Soo |
author_sort | Song, Sang-Wook |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6190494 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-61904942018-10-18 Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial Song, Sang-Wook Kim, Ha-Na Shim, Jae-Yong Yoo, Byeong-Yeon Kim, Dae-Hyun Lee, Sang-Hyun Park, Joo-Sung Kim, Moon-Jong Yoo, Jun-Hyun Cho, BeLong Kang, Hee-Cheol Kim, Kwang-Min Kim, Sung-Soo Kim, Kyung-Soo J Ginseng Res Research Article 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. Elsevier 2018-10 2018-07-24 /pmc/articles/PMC6190494/ /pubmed/30337818 http://dx.doi.org/10.1016/j.jgr.2018.07.002 Text en © 2018 The Korean Society of Ginseng, Published by Elsevier Korea LLC. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Research Article Song, Sang-Wook Kim, Ha-Na Shim, Jae-Yong Yoo, Byeong-Yeon Kim, Dae-Hyun Lee, Sang-Hyun Park, Joo-Sung Kim, Moon-Jong Yoo, Jun-Hyun Cho, BeLong Kang, Hee-Cheol Kim, Kwang-Min Kim, Sung-Soo Kim, Kyung-Soo Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial |
title | Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial |
title_full | Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial |
title_fullStr | Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial |
title_full_unstemmed | Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial |
title_short | Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial |
title_sort | safety and tolerability of korean red ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6190494/ https://www.ncbi.nlm.nih.gov/pubmed/30337818 http://dx.doi.org/10.1016/j.jgr.2018.07.002 |
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