Purpose: To evaluate the safety and efficacy of red ginseng extract powder (OKBT) for treating erectile dysfunction. Materials and Methods: Sixty-nine adult patients with mild to moderate erectile dysfunction of various etiologies were randomized to receive placebo or red ginseng extract powder. The red ginseng extract powder used in the present study was named OKBT. The primary efficacy parameter was response to the International Index of Erectile Function (IIEF) erectile function domain at baseline and week 8. Other IIEF domain scores were evaluated as secondary parameters. For safety evaluation, we performed history taking, physical examination, clinical laboratory tests, and hormonal tests at baseline and week 8. Results: There were no significant differences in the patients' characteristics between the 2 groups. After 8 weeks of administration, primary efficacy (erectile function domain) and all secondary efficacy domains were significantly improved in the OKBT group compared with the placebo group (p < 0.05). Notably, even the domain related to sexual desire, frequency and degree of sexual desire, was also improved in the OKBT group (p < 0.001). There were no significant adverse reactions with OKBT administration, and there were also no significant differences in the results of laboratory tests between the 2 groups after administration. Conclusions: Our data show that red ginseng extract powder can be used as an alternative remedy for Korean men suffering from mild to moderate erectile dysfunction.
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