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NCT Number: NCT01479426

A Trial to Evaluate the Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Sexual Function in Men With Erectile Dysfunction

Korea red ginseng has been used in maintaining vitality throughout the globally and metabolism and actions on neurologic, cardiovascular, and endocrinologic system are studied. KRG has been used in various ailment, and to prove its efficacy for erectile dysfunction an international study on contries other than Korean was performed. In the present study, subjects with borderline organic and psychogenic erectile dysfunction will be included. KRG will be give daily, and placebo will be give as control. Outcomes including libido, erection, sexual activity, and sexual satisfaction will be measured.

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Key information

Conditions

Healthy Subjects(Only Men) Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

19 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

About this study

Among the three main lines of therapy for erectile dysfunction (ED), that is, oral therapy, self-injection therapy and penile prosthesis implantation, the first line therapy is always the first option. Despite the successful advent of sildenafil, the first effective oral agent for ED, further development of new drugs and phytochemical studies of widely known herbal plants are desirable. Furthermore, there seems to be a large population that prefers to use phytotherapies rather than pharmaceutical drugs for their health. Korean red ginseng, a phytotherapy plants, used frequently for ED. Ginseng is one of the most popular herbs in both Eastern and Western countries. It is known as a traditional Asian medicine for stimulation of sexual function and studies have shown the effects of ginseng on relaxation of penile corpus cavernous smooth muscle in many studies. In the present study, the investigators will be determined the real role of Korean red ginseng in the treatment of ED.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • aged 17-70 years
  • IIEF(International Index of Erectile Function)-5 scores ≤ 21 subjects.

Exclusion criteria

  • they had other neurologic or psychiatric disorder
  • significant hepatic or renal function impairment (hepatic enzymes >1.5 times the upper limit of normal and/or serum creatinine >1.8 mg per 100 ml)
  • hypertension (>170/110 mm Hg), hypotension (<90/50 mm Hg) or significant cardiovascular disease (unstable angina, coronary artery disease, myocardial infarction or myocardial revascularization).
  • Peyronie's disease

Treatment and study plan

EFLA400

Dietary Supplement

EFLA400(960mg/day)for 12 weeks

Other names: EFLA400 Korean red ginseng

Placebo

Dietary Supplement

Placebo(960mg/day) for 12 weeks

Primary outcomes

  1. Changes in EF(Erectile Function) Domain

    Time frame: 12 weeks

    EF(erectile function, score 0-20) domain was measured in study visit 1(0 week) and visit 3(12 week).

    The original index consists of 4 Questions. Individual question response is assigned a score of between 0 (worst) to 5 (best) and summed to form a score ranging from 0 (worst) to 20 (best).

Secondary outcomes

  1. Changes in MSHQ (Male Sexual Health Questionnaire)

    Time frame: 12 weeks

    MSHQ(Male Sexual Health Questionnaire) was measured in study visit 1(0 week) and visit 3(12 week).

    The total MSHQ score (25 questions) ranges from 17-130, with higher scores indicating greater sexual function.

  2. GEAQ (Global Efficacy Assessment Question)

    Time frame: after 12weeks of consumption

  3. Changes in Uroflowmetry(Max Flow Rate)

    Time frame: 12 weeks

    uroflowmetry(max flow rate) was measured in study visit 1(0 week) and visit 3(12 week).

  4. Changes in IIEF(International Index of Erectile Function)-Total Domain

    Time frame: 12 weeks

    IIEF(International Index of Erectile Function)-total domain(score range: 5-75) was measured in study visit 1(0 week) and visit 3(12 week).

    IIEF includes 15 questions and addresses the 5 sub-domains of Erectile function, Intercourse satisfaction, Orgasm function, Sexual desire, and Overall satisfaction.

    The IIEF-total domain is the sum of sub-domains. Lower scores indicate severe erectile dysfunction, while higher scores indicate less erectile dysfunction.

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Erectile Dysfunction

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Nov 24, 2011
Registry last updated
Sep 23, 2019

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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