The Efficacy and Safety of New Herbal Formula (KBMSI-2) in the Treatment of Erectile Dysfunction
Status:
Completed
Trial end date:
2013-01-03
Target enrollment:
Participant gender:
Summary
Background: KBMSI-2, which is the herbal formular consisted of Ginseng Radix Rubra, Dioscorea
tenuipes, Cornus officinalis Sieb. Et Zucc, Lycium Chinese Mill, Curcuma logna Linn, Honey,
improved the erectile function by preserving the smooth muscle content and inhibiting the
fibrosis of the corpus cavernosum in STZ-induced diabetic rat model. In this study, the
researchers investigated the efficacy and safety of the herbal formula (KBMSI-2) in the
treatment of ED.
Material and Methods: Patients were instructed to take investigational products (KBMSI-2 6g
or placebo) twice a day for 8 weeks at least 1 hour after food intake. The primary efficacy
variable was the change in the EF domain scores of the IIEF questionnaire from baseline.
Secondary efficacy measures included change in all domain scores of the IIEF from baseline,
change in question 2 and 3 of the SEP2,3, from baseline.