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Safety of red ginseng and herb extract complex (RHC) in menopausal women: A randomized, double-blind, placebo-controlled trial

  • Hyun, Sun Hee (Laboratory of Efficacy Research, Korea Ginseng Corporation) ;
  • Han, Chang-Kyun (Laboratory of Efficacy Research, Korea Ginseng Corporation) ;
  • So, Seung-Ho (Laboratory of Efficacy Research, Korea Ginseng Corporation) ;
  • Park, Soo Kyung (Laboratory of Efficacy Research, Korea Ginseng Corporation) ;
  • Park, Chae-Kyu (Laboratory of Efficacy Research, Korea Ginseng Corporation) ;
  • In, Gyo (Laboratory of Efficacy Research, Korea Ginseng Corporation) ;
  • Lee, Ji Young (Department of Obstetrics and Gynecology, Research Institute of Medical Science, Konkuk University School of Medicine)
  • Received : 2021.06.29
  • Accepted : 2021.11.25
  • Published : 2022.07.01

Abstract

Background: Various treatments are used to relieve menopausal symptoms for women. However, herbal substances are frequently used as complementary and alternative therapies as other treatments can increase ovarian and breast cancer risk. While the herbal substances' therapeutic effect is essential, the safety of their use is considered more important. This study aims to confirm the safety of red ginseng and herb extract complex (RHC), which are used to relieve menopausal symptoms. Methods: This randomized, double-blind, placebo-controlled clinical study recruited and divided 120 women experiencing menopausal symptoms into the RHC and placebo groups (60 women per group). Subjects were administered with 2 g RHC or placebo daily for 12 wk. Adverse reactions, female hormonal changes, and uterine thickness were observed and recorded on wk 0, 6, and 12. Hematologic and blood chemistry tests were also conducted. Results: The reactions of the subjects who received RHC or placebo at least once were analyzed. A total of six adverse reactions occurred in the RHC group, while nine occurred in the placebo group; common reactions observed in both groups were genital, subcutaneous tissue, and vascular disorders. However, there was no statistically significant difference between the administration groups (p = 0.5695), and no severe adverse reactions occurred in both groups.

Keywords

Acknowledgement

All persons who have made substantial contributions to the work reported in the manuscript (e.g., technical help, writing and editing assistance, general support), but who do not meet the criteria for authorship, are named in the Acknowledgements and have given us their written permission to be named. If we have not included an Acknowledgements, then that indicates that we have not received substantial contributions from non-authors.

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