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

Sponsor
Hyun Jun Park (Other)
Overall Status
Completed
CT.gov ID
NCT02413099
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
11.1
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Jan 3, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: KBMSI-2 6gm

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
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.
Other Names:
  • Better man (brand name)

    		•
    Placebo Comparator: Placebo

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

    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.
    Other Names:
  • Better man (brand name)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in the EF domain scores of the IIEF questionnaire from baseline [Baseline, 4weeks, 8weeks]

      calculated by comparing total scores from questions 1 to 5 and 15 from IIEF questionnaire

    Secondary Outcome Measures

    1. Change in all domain scores of the IIEF from baseline [Baseline, 4weeks, 8weeks]

    2. 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]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Urology, Pusan National University Hospital Busan Korea, Republic of 602-739

    Sponsors and Collaborators

    • Hyun Jun Park

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hyun Jun Park, Professor, Pusan National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02413099
    Other Study ID Numbers:
    • KBMSI-2 Study
    First Posted:
    Apr 9, 2015
    Last Update Posted:
    Aug 29, 2018
    Last Verified:
    Aug 1, 2018
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of Aug 29, 2018