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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01479426
First received: November 16, 2011
Last updated: November 23, 2011
Last verified: December 2010

November 16, 2011
November 23, 2011
December 2010
March 2012   (final data collection date for primary outcome measure)
IIEF-5 score [ Time Frame: Change from baseline in IIEF-5 score at 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01479426 on ClinicalTrials.gov Archive Site
  • MSHQ [ Time Frame: Change from baseline in MSHQ score at 12 weeks ] [ Designated as safety issue: Yes ]
  • GEAQ [ Time Frame: Change from baseline in GEAQ score at 12 weeks ] [ Designated as safety issue: Yes ]
  • uroflowmetry(max flow rate) [ Time Frame: Change from baseline in uroflowmetry at 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Trial to Evaluate the Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Sexual Function in Men With Erectile Dysfunction
Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on 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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Healthy Subjects(Only Men)
  • Dietary Supplement: EFLA400
    EFLA400(960mg/day)for 12 weeks
    Other Name: EFLA400 Korean red ginseng
  • Dietary Supplement: Placebo
    Placebo(960mg/day) for 12 weeks
  • Experimental: EFLA400(960mg)
    Intervention: Dietary Supplement: EFLA400
  • Placebo Comparator: Placebo(960mg)
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
80
July 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • aged 35-65 years
  • IIEF-5 scores between 13 and 21

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
Male
35 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01479426
LOTTE-MS-EFLA400
Yes
Not Provided
Chonbuk National University Hospital
Not Provided
Principal Investigator: Jong-Kwan Park, MD Chonbuk National University Hospital
Chonbuk National University Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP