A Double-Blind, Randomized, Crossover Comparative Study for Evaluating the Clinical Safety of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE)
المؤلفون المشاركون
Kobayashi, Yoshinori
Odaguchi, Hiroshi
Sekine, Mariko
Hyuga, Sumiko
Hanawa, Toshihiko
Hoshi, Keika
Sasaki, Yoshinobu
Aso, Masako
Yang, Jinwei
Hyuga, Masashi
Hakamatsuka, Takashi
Goda, Yukihiro
Kumagai, Yuji
المصدر
Evidence-Based Complementary and Alternative Medicine
العدد
المجلد 2018، العدد 2018 (31 ديسمبر/كانون الأول 2018)، ص ص. 1-8، 8ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2018-08-05
دولة النشر
مصر
عدد الصفحات
8
التخصصات الرئيسية
الملخص EN
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 causal relationship to the study drugs (EHE: 8; EFE: 3) were noted; all events were mild in severity.
With regard to the incidence of adverse events, EHE and EFE administration, respectively, accounted for 4 cases (out of 12 subjects, similarly below) and 1 case of increased pulse rate (p=0.32) and 3 cases and 1 case of insomnia (p=0.59).
Further, there was one case of hot flashes (p=1.00) due to EFE administration and one case of dysuria (p=1.00) due to EHE administration.
There were no significant differences in the incidences of adverse events between EHE administration and EFE administration.
Therefore, we concluded that EFE is not inferior to EHE in terms of safety.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Odaguchi, Hiroshi& Sekine, Mariko& Hyuga, Sumiko& Hanawa, Toshihiko& Hoshi, Keika& Sasaki, Yoshinobu…[et al.]. 2018. 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،Vol. 2018, no. 2018, pp.1-8.
https://search.emarefa.net/detail/BIM-1155247
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Odaguchi, Hiroshi…[et al.]. 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 No. 2018 (2018), pp.1-8.
https://search.emarefa.net/detail/BIM-1155247
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Odaguchi, Hiroshi& Sekine, Mariko& Hyuga, Sumiko& Hanawa, Toshihiko& Hoshi, Keika& Sasaki, Yoshinobu…[et al.]. 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. 2018. Vol. 2018, no. 2018, pp.1-8.
https://search.emarefa.net/detail/BIM-1155247
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1155247
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر