Clinical Research Testing the Usefulness of Ephedrine Alkaloids-free Ephedra Herb Extract.

Abstract

We aimed to test the clinical usefulness of ephedrine alkaloids-free Ephedra Herb extract (EFE), which has been proven to be effective and safe in animal studies. First, we performed a safety trial with 7 healthy volunteers, and increased white blood cell counts were observed in 2. However, it was unknown whether this observation was a result of EFE administration. Then, we implemented a controlled, double-blind, randomized crossover trial as the second safety trial for EFE. The trial was conducted under strict conditions, and the participants were managed in the hospital and monitored using an increased number of endpoints. Twelve healthy volunteers were randomly allocated to group 1, who were administered EFE first, or group 2, who were administered Ephedra Herb first. In both groups, the drug was administered for 6 d. After a 4-week washout period with no drug administration, each group was administered the alternate drug for 6 d. In the third stage, a dose-response trial is planned to test the effectiveness and safety of EFE on chronic joint pain. Patients with chronic knee joint pain will be randomly allocated to three groups, and each group will be administered EFE prepared from different amounts of Ephedra Herb. Until this stage, the studies will be conducted as investigator-initiated clinical trials. In the fourth stage, industry-sponsored clinical trials will be planned. This multicenter trial will involve 300 patients with joint pain, neuralgia, and/or muscle pain.