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

NCT02413099 | Completed Phase 4

• 1 other identifier: KBMSI-2 Study
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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 SEP2,3, from baseline.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in all domain scores of the IIEF from baseline

  Baseline, 4weeks, 8weeks

• 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

Study Arms (2)

KBMSI-2 6gm

EXPERIMENTAL

Patients were instructed to take investigational products (KBMSI-2 6g) twice a day for 8weeks at least 1 hour after food intake

Drug: KBMSI-2

Placebo

PLACEBO COMPARATOR

Patients were instructed to take placebo twice a day for 8weeks at least 1 hour after food intake

Drug: KBMSI-2

Interventions

KBMSI-2 DRUG

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.

Also known as: Better man (brand name)

KBMSI-2 6gm; Placebo

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hyun Jun Park: lead

Study Sites (1)

Department of Urology, Pusan National University Hospital

Busan, 602-739, South Korea

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

KBMSI-2

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 9, 2015
• Study Start: February 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: January 3, 2013
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

KR (1)