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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects(Only Men)
• Intervention / Treatment: Dietary supplement: EFLA400; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EFLA400(960mg)	Dietary supplement: EFLA400; EFLA400(960mg/day)for 12 weeks; Other Names: EFLA400 Korean red ginseng
Placebo Comparator: Placebo(960mg)	Dietary supplement: Placebo; Placebo(960mg/day) for 12 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital
• Investigators: Principal Investigator: Jong-Kwan Park, MD, Chonbuk National University Hospital

Publications and helpful links

General Publications

• 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:CD012654. doi: 10.1002/14651858.CD012654.pub2.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 23, 2011
• First Posted (Estimate): November 24, 2011

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Erectile dysfunction; Korean Red Ginseng; IIEF(International Index of Erectile Function); MSHQ(Male Sexual Health Questionnaire,)
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: LOTTE-MS-EFLA400