Clinical trial NCT01479426: A Trial to Evaluate the Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Sexual Function in Men With Erectile Dysfunction
Official title: Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects(Only Men)
Keywords: Erectile dysfunction
Korean Red Ginseng
IIEF(International Index of Erectile Function)
MSHQ(Male Sexual Health Questionnaire,)
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 80
Sex: MALE
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 criteria: 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

Primary outcomes:
measure: Changes in EF(Erectile Function) Domain
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in MSHQ (Male Sexual Health Questionnaire)
timeFrame: 12 weeks
measure: GEAQ (Global Efficacy Assessment Question)
timeFrame: after 12weeks of consumption
measure: Changes in Uroflowmetry(Max Flow Rate)
timeFrame: 12 weeks
measure: Changes in IIEF(International Index of Erectile Function)-Total Domain
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Jong-Kwan Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee HW, Lee MS, Kim TH, Alraek T, Zaslawski C, Kim JW, Moon DG. Ginseng for erectile dysfunction. Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD012654. doi: 10.1002/14651858.CD012654.pub2.