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

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ClinicalTrials.gov Identifier: NCT02413099
Recruitment Status : Completed
First Posted : April 9, 2015
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hyun Jun Park, Pusan National University Hospital

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
Erectile Dysfunction Drug: KBMSI-2 Phase 4

Study Type : Interventional  (Clinical Trial)
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 : February 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 3, 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Better man (brand name)




Primary Outcome Measures :
  1. Change in the EF domain scores of the IIEF questionnaire from baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413099


Locations
Korea, Republic of
Department of Urology, Pusan National University Hospital
Busan, Korea, Republic of, 602-739
Sponsors and Collaborators
Hyun Jun Park

Responsible Party: Hyun Jun Park, Professor, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT02413099     History of Changes
Other Study ID Numbers: KBMSI-2 Study
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders