A Trial to Evaluate the Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Sexual Function in Men With Erectile Dysfunction
Primary Purpose
Healthy Subjects(Only Men)
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EFLA400
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Subjects(Only Men) focused on measuring Erectile dysfunction, Korean Red Ginseng, IIEF(International Index of Erectile Function), MSHQ(Male Sexual Health Questionnaire,)
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
Sites / Locations
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EFLA400(960mg)
Placebo(960mg)
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
GEAQ (Global Efficacy Assessment Question)
Changes in Uroflowmetry(Max Flow Rate)
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
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.
Full Information
NCT ID
NCT01479426
First Posted
November 16, 2011
Last Updated
August 21, 2019
Sponsor
Chonbuk National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01479426
Brief Title
A Trial to Evaluate the Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Sexual Function in Men With Erectile Dysfunction
Official Title
Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects(Only Men)
Keywords
Erectile dysfunction, Korean Red Ginseng, IIEF(International Index of Erectile Function), MSHQ(Male Sexual Health Questionnaire,)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EFLA400(960mg)
Arm Type
Experimental
Arm Title
Placebo(960mg)
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
EFLA400
Other Intervention Name(s)
EFLA400 Korean red ginseng
Intervention Description
EFLA400(960mg/day)for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo(960mg/day) for 12 weeks
Primary Outcome Measure Information:
Title
Changes in EF(Erectile Function) Domain
Description
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
Secondary Outcome Measure Information:
Title
Changes in MSHQ (Male Sexual Health Questionnaire)
Description
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
Title
GEAQ (Global Efficacy Assessment Question)
Time Frame
after 12weeks of consumption
Title
Changes in Uroflowmetry(Max Flow Rate)
Description
uroflowmetry(max flow rate) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in IIEF(International Index of Erectile Function)-Total Domain
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Kwan Park, MD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
33871063
Citation
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.
Results Reference
derived
Learn more about this trial
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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