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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Chonbuk National University Hospital.
Recruitment status was:  Enrolling by invitation
Information provided by:
Chonbuk National University Hospital Identifier:
First received: November 16, 2011
Last updated: November 23, 2011
Last verified: December 2010
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.

Condition Intervention Phase
Healthy Subjects(Only Men)
Dietary Supplement: EFLA400
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Erectile Dysfunction

Resource links provided by NLM:

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • IIEF-5 score [ Time Frame: Change from baseline in IIEF-5 score at 12 weeks ]

Secondary Outcome Measures:
  • MSHQ [ Time Frame: Change from baseline in MSHQ score at 12 weeks ]
  • GEAQ [ Time Frame: Change from baseline in GEAQ score at 12 weeks ]
  • uroflowmetry(max flow rate) [ Time Frame: Change from baseline in uroflowmetry at 12 weeks ]

Estimated Enrollment: 80
Study Start Date: December 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EFLA400(960mg) Dietary Supplement: EFLA400
EFLA400(960mg/day)for 12 weeks
Other Name: EFLA400 Korean red ginseng
Placebo Comparator: Placebo(960mg) Dietary Supplement: Placebo
Placebo(960mg/day) for 12 weeks

Detailed Description:
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.

Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01479426

Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
Principal Investigator: Jong-Kwan Park, MD Chonbuk National University Hospital
  More Information Identifier: NCT01479426     History of Changes
Other Study ID Numbers: LOTTE-MS-EFLA400
Study First Received: November 16, 2011
Last Updated: November 23, 2011

Keywords provided by Chonbuk National University Hospital:
Erectile dysfunction
Korean Red Ginseng

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders processed this record on April 28, 2017