Healthy Subjects(Only Men)
Conditions
Keywords
Erectile dysfunction, Korean Red Ginseng, IIEF(International Index of Erectile Function), MSHQ(Male Sexual Health Questionnaire,)
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.
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.
Interventions
DIETARY_SUPPLEMENTEFLA400
EFLA400(960mg/day)for 12 weeks
DIETARY_SUPPLEMENTPlacebo
Placebo(960mg/day) for 12 weeks
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
19 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in EF(Erectile Function) Domain | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in MSHQ (Male Sexual Health Questionnaire) | 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. |
| GEAQ (Global Efficacy Assessment Question) | after 12weeks of consumption | — |
| Changes in Uroflowmetry(Max Flow Rate) | 12 weeks | uroflowmetry(max flow rate) was measured in study visit 1(0 week) and visit 3(12 week). |
| Changes in IIEF(International Index of Erectile Function)-Total Domain | 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. |
Countries
South Korea
Participant flow
Recruitment details
Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
Pre-assignment details
The criteria were an age from 19 to 70 years, IIEF(International Index of Erectile Function)-5 scores ≤ 21 subjects.
Participants by arm
| Arm | Count |
|---|---|
| EFLA400(960mg) | 40 |
| Placebo(960mg) | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Placebo(960mg) | EFLA400(960mg) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 40 Participants | 80 Participants |
| Age, Continuous | 59.70 years STANDARD_DEVIATION 7.59 | 60.13 years STANDARD_DEVIATION 6.65 | 59.91 years STANDARD_DEVIATION 7.09 |
| Region of Enrollment Korea, Republic of | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 40 Participants | 40 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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).
Time frame: 12 weeks
Population: per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EFLA400 | Changes in EF(Erectile Function) Domain | Pre | 11.53 Scores on a scale | Standard Deviation 4.33 |
| EFLA400 | Changes in EF(Erectile Function) Domain | Post | 14.56 Scores on a scale | Standard Deviation 4.92 |
| Placebo | Changes in EF(Erectile Function) Domain | Pre | 12.89 Scores on a scale | Standard Deviation 4.19 |
| Placebo | Changes in EF(Erectile Function) Domain | Post | 16.46 Scores on a scale | Standard Deviation 5.16 |
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.
Time frame: 12 weeks
Population: per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EFLA400 | Changes in IIEF(International Index of Erectile Function)-Total Domain | Pre | 37.83 Scores on a scale | Standard Deviation 10.89 |
| EFLA400 | Changes in IIEF(International Index of Erectile Function)-Total Domain | Post | 47.11 Scores on a scale | Standard Deviation 12.04 |
| Placebo | Changes in IIEF(International Index of Erectile Function)-Total Domain | Pre | 41.00 Scores on a scale | Standard Deviation 10.3 |
| Placebo | Changes in IIEF(International Index of Erectile Function)-Total Domain | Post | 50.41 Scores on a scale | Standard Deviation 12.58 |
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.
Time frame: 12 weeks
Population: per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EFLA400 | Changes in MSHQ (Male Sexual Health Questionnaire) | Pre | 70.28 Scores on a scale | Standard Deviation 12.98 |
| EFLA400 | Changes in MSHQ (Male Sexual Health Questionnaire) | Post | 82.22 Scores on a scale | Standard Deviation 17.34 |
| Placebo | Changes in MSHQ (Male Sexual Health Questionnaire) | Pre | 71.62 Scores on a scale | Standard Deviation 14.8 |
| Placebo | Changes in MSHQ (Male Sexual Health Questionnaire) | Post | 83.81 Scores on a scale | Standard Deviation 19.19 |
Secondary
Changes in Uroflowmetry(Max Flow Rate)
uroflowmetry(max flow rate) was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 12 weeks
Population: per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EFLA400 | Changes in Uroflowmetry(Max Flow Rate) | Post | 20.63 m/sec | Standard Deviation 8.96 |
| EFLA400 | Changes in Uroflowmetry(Max Flow Rate) | Pre | 19.65 m/sec | Standard Deviation 9.48 |
| Placebo | Changes in Uroflowmetry(Max Flow Rate) | Post | 20.95 m/sec | Standard Deviation 9.46 |
| Placebo | Changes in Uroflowmetry(Max Flow Rate) | Pre | 17.64 m/sec | Standard Deviation 6.47 |
Secondary
GEAQ (Global Efficacy Assessment Question)
Time frame: after 12weeks of consumption