NCT01479426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

September 23, 2019

Completed
Last Updated

September 23, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

November 16, 2011

Results QC Date

July 26, 2012

Last Update Submit

August 21, 2019

Conditions

Healthy Subjects(Only Men)

Keywords

Erectile dysfunctionKorean Red GinsengIIEF(International Index of Erectile Function)MSHQ(Male Sexual Health Questionnaire,)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Changes in MSHQ (Male Sexual Health Questionnaire)

    12 weeks

  • GEAQ (Global Efficacy Assessment Question)

    after 12weeks of consumption

  • Changes in Uroflowmetry(Max Flow Rate)

    12 weeks

  • Changes in IIEF(International Index of Erectile Function)-Total Domain

    12 weeks

Study Arms (2)

EFLA400(960mg)

EXPERIMENTAL
Dietary Supplement: EFLA400

Placebo(960mg)

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

EFLA400DIETARY_SUPPLEMENT

EFLA400(960mg/day)for 12 weeks

Also known as: EFLA400 Korean red ginseng
EFLA400(960mg)
PlaceboDIETARY_SUPPLEMENT

Placebo(960mg/day) for 12 weeks

Placebo(960mg)

Eligibility Criteria

Age19 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 17-70 years
  • IIEF(International Index of Erectile Function)-5 scores ≤ 21 subjects.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33871063DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Results Point of Contact

Title
Dr. Jong-Kwan Park, MD
Organization
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
rain@chonbuk.ac.kr
82-63-276-8284

Study Officials

  • Jong-Kwan Park, MD

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

November 16, 2011

First Posted

November 24, 2011

Study Start

December 1, 2010

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

September 23, 2019

Results First Posted

September 23, 2019

Record last verified: 2019-08

Locations

KR(1)