The Efficacy and Safety of New Herbal Formula (KBMSI-2) in the Treatment of Erectile Dysfunction

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413099
• Other study ID #: KBMSI-2 Study
• Status: Completed
• Phase: Phase 4
• Start date: February 2012
• Est. completion date: January 3, 2013

Study information

• Verified date: August 2018
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 3, 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 40 Years

Eligibility

Inclusion criteria were as follows:

• men with history of ED for at least 6 months according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance);

• erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) questionnaire = 25;

• age range between 19 and 40 years old;

• patients were required to be involved in a stable, monogamous relationship with a female sexual partner and having failed >50% of at least four sexual attempts during the run-in period.

Exclusion criteria were as follows:

• Men with the following conditions were excluded from the study:

• penile anatomical defects,

• spinal cord injury,

• radical prostatectomy,

• and radical pelvic surgery;

• a primary diagnosis of another sexual disorder;

• uncontrolled DM (HBA1C> 12%);

• serum creatinine>2.5mg/dL;

• major uncontrolled psychiatric disorder;

• history of major hematological, renal, or hepatic abnormalities;

• recent (within the previous 6 months) history of cardiovascular disease, stroke or myocardial infarction, cardiac failure, unstable angina, life-threatening arrhythmia and a history of alcoholism or substance abuse.

• Patients having taken PDE5 inhibitors and testosterone replacement therapy within 2 weeks were excluded in the study. Concomitant use of ED treatment was forbidden.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• KBMSI-2
The KBMSI-2 capsules (6gm/capsule) and placebo were provided by Korean Bio Medical Science Institute (Seoul, Korea). KBMSI-2 was analyzed by high-performance liquid chromatography. KBMSI-2 contained major ginsenoside-Rb1: 260.53ug/g, -Rb2: 543.91ug/g, -Rc: 424.92ug/g, -Re: 377.32ug/g, -Rf: 1160.55ug/g, -Rg1: 703.97ug/g, Curcumin 60.73ug/g, Allantoin 98.66ug.g, and Loganin 744.13ug/g. During the study period, two capsules were taken daily for 8 weeks. The placebo capsules were identical in shape, color, and taste.

Locations

Country	Name	City	State
Korea, Republic of	Department of Urology, Pusan National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Hyun Jun Park

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the EF domain scores of the IIEF questionnaire from baseline	calculated by comparing total scores from questions 1 to 5 and 15 from IIEF questionnaire	Baseline, 4weeks, 8weeks
Secondary	Change in all domain scores of the IIEF from baseline		Baseline, 4weeks, 8weeks
Secondary	change in question 2 and 3 of the Sexual Encounter Profile (SEP2: Were you able to insert your penis in your partner's vagina? SEP3: Did your erection last long enough for you to have a successful intercourse?) from baseline	change in question 2 and 3 of the Sexual Encounter Profile (SEP2: Were you able to insert your penis in your partner's vagina? SEP3: Did your erection last long enough for you to have a successful intercourse?) from baseline	Baseline, 4weeks, 8weeks