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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy Subjects(Only Men)

Intervention / Treatment
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* Dietary Supplement: EFLA400
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EFLA400(960mg)<br> | Dietary Supplement: EFLA400<br>* EFLA400(960mg/day)for 12 weeks<br>* Other names: EFLA400 Korean red ginseng;|
| Placebo Comparator: Placebo(960mg)<br> | Dietary Supplement: Placebo<br>* Placebo(960mg/day) for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in EF(Erectile Function) Domain | 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). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in MSHQ (Male Sexual Health Questionnaire) | 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. | 12 weeks | 
| GEAQ (Global Efficacy Assessment Question) |  | after 12weeks of consumption | 
| Changes in Uroflowmetry(Max Flow Rate) | uroflowmetry(max flow rate) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in IIEF(International Index of Erectile Function)-Total Domain | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile dysfunction, Korean Red Ginseng, IIEF(International Index of Erectile Function), MSHQ(Male Sexual Health Questionnaire,)