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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Healthy Subjects(Only Men)	Dietary Supplement: EFLA400; Dietary Supplement: Placebo	Phase 2; Phase 3

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Prevention
Official Title:	Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Erectile Dysfunction
Study Start Date :	December 2010
Estimated Primary Completion Date :	March 2012
Estimated Study Completion Date :	July 2012

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. IIEF-5 score [ Time Frame: Change from baseline in IIEF-5 score at 12 weeks ]

Secondary Outcome Measures :

1. MSHQ [ Time Frame: Change from baseline in MSHQ score at 12 weeks ]
2. GEAQ [ Time Frame: Change from baseline in GEAQ score at 12 weeks ]
3. uroflowmetry(max flow rate) [ Time Frame: Change from baseline in uroflowmetry at 12 weeks ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	35 Years to 65 Years (Adult)
Sexes 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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT01479426 History of Changes
Other Study ID Numbers:	LOTTE-MS-EFLA400
First Posted:	November 24, 2011
Last Update Posted:	November 24, 2011
Last Verified:	December 2010

Keywords provided by Chonbuk National University Hospital:

Erectile dysfunction; Korean Red Ginseng; IIEF; MSHQ

Additional relevant MeSH terms:

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