A Double-Blind, Randomized, Crossover Comparative Study for Evaluating the Clinical Safety of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE)

Evidence-based Complementary and Alternative Medicine : ECAM
Hiroshi OdaguchiYuji Kumagai

Abstract

Ephedra Herb is an important crude drug; it is used in various Traditional Japanese Medicine (Kampo) formulations. Its significant pharmacological effects have been believed to be attributed to ephedrine and pseudoephedrine, which sometimes induce adverse effects. On the other hand, it has been reported that some of these pharmacological effects are not dependent on ephedrine or pseudoephedrine. Ephedrine alkaloids-free Ephedra Herb extract has been newly developed. It has been reported to have analgesic, anti-influenza, and antimetastatic effects. This clinical trial was aimed at verifying the noninferiority of EFE's safety compared to that of Ephedra Herb extract (EHE) in humans. This was a single-institution, double-blinded, randomized, two-drug, two-stage, crossover comparative study. Twelve healthy male subjects were equally and randomly allocated into two groups: prior administration of EFE (EFE-P) and prior administration of EHE (EHE-P). In Stage 1, EFE and EHE were orally administered to the EFE-P and EHE-P groups, respectively, for six days. After a 4-week washout period, Stage 2 was initiated wherein the subjects were given a study drug different from Stage 1 study drug for six days. Eleven adverse events with a causa...Continue Reading

References

Oct 1, 1980·Chemical & Pharmaceutical Bulletin·H HikinoM Tamada
Aug 1, 1985·Planta medica·Y KasaharaK Ohuchi
May 15, 2013·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Yoshiaki AmakuraYukihiro Goda
Feb 2, 2018·Biological & Pharmaceutical Bulletin·Hiroaki TakemotoYoshinori Kobayashi

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Citations

Nov 7, 2019·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·Hiroshi OdaguchiToshihiko Hanawa
May 19, 2020·Evidence-based Complementary and Alternative Medicine : ECAM·Zhou LiaoZhifu Ai

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Methods Mentioned

BETA
ion-exchange column chromatography
column chromatography

Software Mentioned

KiRS
JMP

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