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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Erectile Dysfunction

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]
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.

  Eligibility
Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479426

Locations
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
Investigators
Principal Investigator: Jong-Kwan Park, MD Chonbuk National University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01479426     History of Changes
Other Study ID Numbers: LOTTE-MS-EFLA400
Study First Received: November 16, 2011
Last Updated: November 23, 2011
Health Authority: South Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on March 01, 2015