A Trial to Evaluate the Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Sexual Function in Men With Erectile Dysfunction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01479426|
Recruitment Status : Completed
First Posted : November 24, 2011
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects(Only Men)||Dietary Supplement: EFLA400 Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Erectile Dysfunction|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||February 2012|
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
- Changes in EF(Erectile Function) Domain [ Time Frame: 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).
- Changes in MSHQ (Male Sexual Health Questionnaire) [ Time Frame: 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) [ Time Frame: after 12weeks of consumption ]
- Changes in Uroflowmetry(Max Flow Rate) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479426
|Korea, Republic of|
|Clinical Trial Center for Functional Foods; Chonbuk National University Hospital|
|Jeonju, Jeollabuk-do, Korea, Republic of, 560-822|
|Principal Investigator:||Jong-Kwan Park, MD||Chonbuk National University Hospital|