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

Healthy Subjects(Only Men) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479426
• Other study ID #: LOTTE-MS-EFLA400
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: August 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Healthy Subjects(Only Men)

Intervention

Dietary Supplement:
• EFLA400
EFLA400(960mg/day)for 12 weeks
• Placebo
Placebo(960mg/day) for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	GEAQ (Global Efficacy Assessment Question)		after 12weeks of consumption
Secondary	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
Secondary	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