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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EFLA400(960mg) | Experimental |
| |
| Placebo(960mg) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EFLA400 | Dietary Supplement | EFLA400(960mg/day)for 12 weeks |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong-Kwan Park, MD | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 560-822 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33871063 | Derived | 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(4):CD012654. doi: 10.1002/14651858.CD012654.pub2. |
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The criteria were an age from 19 to 70 years, IIEF(International Index of Erectile Function)-5 scores ≤ 21 subjects.
Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | EFLA400 | EFLA400(2times/day, 2capsules/day, 960mg/day) for 12weeks EFLA400: Red Ginseng (90%) and Crataegus pinnatifida Bunge (10%) to high temperature (110 ~ 120 ˚ C) were reacted in the ginsenoside Rg3 increased by alcohol extraction after manufacture. |
| FG001 | Placebo | Placebo(2times/day, 2capsules/day, 960mg/day) for 12weeks Placebo : Amount and calorie of placebo are same with EFLA400 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EFLA400(960mg) | |
| BG001 | Placebo(960mg) | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | per protocol analysis | Posted | Mean | Standard Deviation | Scores on a scale | 12 weeks |
|
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Serious and/or other [non-serious] adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EFLA400(960mg) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jong-Kwan Park, MD | Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | 82-63-276-8284 | rain@chonbuk.ac.kr |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| Placebo | Dietary Supplement | Placebo(960mg/day) for 12 weeks |
|
| 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 |
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | per protocol analysis | Posted | Mean | Standard Deviation | Scores on a scale | 12 weeks |
|
|
|
| Secondary | GEAQ (Global Efficacy Assessment Question) | Not Posted | after 12weeks of consumption | Participants |
| Secondary | Changes in Uroflowmetry(Max Flow Rate) | uroflowmetry(max flow rate) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | m/sec | 12 weeks |
|
|
|
| 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. | per protocol analysis | Posted | Mean | Standard Deviation | Scores on a scale | 12 weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo(960mg) | 0 | 0 | 0 | 0 |
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |