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Completed

NCT Number: NCT02413099

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

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.

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Key information

Conditions

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

Age range

19 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Department of Urology, Pusan National University Hospital

Busan, 602-739, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Better man (brand name)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hyun Jun Park

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 9, 2015
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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