Safety and Efficacy of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE) for Mild COVID-19: A Double-Blind, Placebo-Controlled, Randomized Comparative Trial

Safety and Efficacy of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE) for Mild COVID-19: A Double-Blind, Placebo-Controlled, Randomized Comparative Trial

Several Ephedra Herb-containing Kampo medicines are common initial treatments for various infections; however, the ephedrine alkaloids in Ephedra Herb can cause side effects by stimulating adrenergic receptors. Accordingly, an ephedrine alkaloids-free Ephedra Herb Extract (EFE) has been developed. T...

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Main Authors: Hiroshi Odaguchi, Sumiko Hyuga, Mariko Sekine, Hirofumi Michimae, Masashi Hyuga, Nahoko Uchiyama, Masashi Uema, Yuji Kumagai, Yusuke Suzuki, Shigeki Nabeshima, Norio Omagari, Yohei Doi, Kunihiro Yamaoka, Koji Miyazaki, Susumu Fuji, Yoshihiro Umezawa, Shiho Kodera, Hirotaka Nagashima, Wataru Hirose, Yukihiro Goda
Format: Article
Language:English
Published: MDPI AG 2025-03-01
Series:Microorganisms
Subjects:
SARS-CoV-2
COVID-19
EFE
DB-RCT
Kampo medicine
crude drug
Online Access:https://www.mdpi.com/2076-2607/13/3/641
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Summary:Several Ephedra Herb-containing Kampo medicines are common initial treatments for various infections; however, the ephedrine alkaloids in Ephedra Herb can cause side effects by stimulating adrenergic receptors. Accordingly, an ephedrine alkaloids-free Ephedra Herb Extract (EFE) has been developed. This study aimed to evaluate whether EFE can be used effectively and safely in patients with mild coronavirus disease 2019 (COVID-19). We randomized patients with mild COVID-19 to receive EFE equivalent to 6 g of Ephedra Herb per day or a placebo for 14 days. The primary efficacy endpoint was the non-aggravation rate up to Day 15. We allocated 41 and 40 patients to the EFE and placebo groups, respectively. All participants were included in the mITT and safety analysis populations [male ratio, mean age: 31.7%, 42.0 years (EFE); 17.5%, 43.2 years (placebo)]. The non-aggravation rate up to Day 15 for the primary endpoint was 100.0% and 94.6% in the EFE and placebo group, respectively, with no between-group difference. The number of days to the improvement in nausea symptoms was significantly shorter in the EFE group. One patient in the placebo group discontinued the trial due to a side effect. Although EFE demonstrated safety in patients with mild COVID-19, it did not show superior efficacy compared to placebo for symptoms other than nausea.
ISSN:2076-2607

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