N/A
N=80
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)
Bottom Line
View on ClinicalTrials.gov: NCT01479426 ↗Enrolled (actual)
80
Serious AEs
—
Results posted
Sep 2019
Primary outcome: Primary: Changes in EF(Erectile Function) Domain — 11.53; 12.89; 14.56; 16.46 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EFLA400 (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Male
- Sponsor
- Chonbuk National University Hospital
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in EF(Erectile Function) Domain |
11.53; 12.89; 14.56; 16.46 | — |
| SECONDARY Changes in MSHQ (Male Sexual Health Questionnaire) |
70.28; 71.62; 82.22; 83.81 | — |
| SECONDARY GEAQ (Global Efficacy Assessment Question) |
— | — |
| SECONDARY Changes in Uroflowmetry(Max Flow Rate) |
19.65; 17.64; 20.63; 20.95 | — |
| SECONDARY Changes in IIEF(International Index of Erectile Function)-Total Domain |
37.83; 41.00; 47.11; 50.41 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01479426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.