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

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ClinicalTrials.gov Identifier: NCT01479426
Recruitment Status : Completed
First Posted : November 24, 2011
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : December 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Changes in EF(Erectile Function) Domain [ Time Frame: 12 weeks ]

    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).



Secondary Outcome Measures :
  1. Changes in MSHQ (Male Sexual Health Questionnaire) [ Time Frame: 12 weeks ]

    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.


  2. GEAQ (Global Efficacy Assessment Question) [ Time Frame: after 12weeks of consumption ]
  3. Changes in Uroflowmetry(Max Flow Rate) [ Time Frame: 12 weeks ]
    uroflowmetry(max flow rate) was measured in study visit 1(0 week) and visit 3(12 week).

  4. Changes in IIEF(International Index of Erectile Function)-Total Domain [ Time Frame: 12 weeks ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479426


Locations
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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
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Principal Investigator: Jong-Kwan Park, MD Chonbuk National University Hospital
More Information
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Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01479426    
Other Study ID Numbers: LOTTE-MS-EFLA400
First Posted: November 24, 2011    Key Record Dates
Results First Posted: September 23, 2019
Last Update Posted: September 23, 2019
Last Verified: August 2019
Keywords provided by Soo-Wan Chae, Chonbuk National University Hospital:
Erectile dysfunction
Korean Red Ginseng
IIEF(International Index of Erectile Function)
MSHQ(Male Sexual Health Questionnaire,)
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders