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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
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Chonbuk National University Hospital.
Recruitment status was: Enrolling by invitation
Recruitment status was: Enrolling by invitation
Sponsor:
Chonbuk National University Hospital
Information provided by:
Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01479426
First received: November 16, 2011
Last updated: November 23, 2011
Last verified: December 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Healthy Subjects(Only Men) | Dietary Supplement: EFLA400 Dietary Supplement: Placebo | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Prevention |
| Official Title: | Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Erectile Dysfunction |
Resource links provided by NLM:
Further study details as provided by Chonbuk National University Hospital:
Primary Outcome Measures:
- IIEF-5 score [ Time Frame: Change from baseline in IIEF-5 score at 12 weeks ]
Secondary Outcome Measures:
- MSHQ [ Time Frame: Change from baseline in MSHQ score at 12 weeks ]
- GEAQ [ Time Frame: Change from baseline in GEAQ score at 12 weeks ]
- uroflowmetry(max flow rate) [ Time Frame: Change from baseline in uroflowmetry at 12 weeks ]
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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| Ages Eligible for Study: | 35 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- aged 35-65 years
- IIEF-5 scores between 13 and 21
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01479426
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479426
Locations
| 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
| Principal Investigator: | Jong-Kwan Park, MD | Chonbuk National University Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT01479426 History of Changes |
| Other Study ID Numbers: |
LOTTE-MS-EFLA400 |
| Study First Received: | November 16, 2011 |
| Last Updated: | November 23, 2011 |
Keywords provided by Chonbuk National University Hospital:
|
Erectile dysfunction Korean Red Ginseng IIEF MSHQ |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Mental Disorders |
ClinicalTrials.gov processed this record on June 23, 2017