Ignite Creation Date:
2024-05-06 @ 3:57 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02413099
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2015-04-06
Brief Title:
The Efficacy and Safety of New Herbal Formula KBMSI-2 in the Treatment of Erectile Dysfunction
Sponsor:
Hyun Jun Park
Organization:
Pusan National University Hospital
Study Overview
Official Title:
The Efficacy and Safety of New Herbal Formula KBMSI-2 in the Treatment of Erectile Dysfunction A Randomized Double-Blind Placebo-Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 SEP23 from baseline
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 SEP23 from baseline
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None