Trial Outcomes & Findings for A Trial to Evaluate the Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Sexual Function in Men With Erectile Dysfunction (NCT NCT01479426)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-09-23

Participant Flow

Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

The criteria were an age from 19 to 70 years, IIEF(International Index of Erectile Function)-5 scores ≤ 21 subjects.

Participant milestones

Participant milestones
Measure	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.	Placebo Placebo(2times/day, 2capsules/day, 960mg/day) for 12weeks Placebo : Amount and calorie of placebo are same with EFLA400
Overall Study STARTED	40	40
Overall Study COMPLETED	36	37
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial to Evaluate the Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Sexual Function in Men With Erectile Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EFLA400(960mg) n=40 Participants	Placebo(960mg) n=40 Participants	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	60.13 years STANDARD_DEVIATION 6.65 • n=5 Participants	59.70 years STANDARD_DEVIATION 7.59 • n=7 Participants	59.91 years STANDARD_DEVIATION 7.09 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Region of Enrollment Korea, Republic of	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

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).

Outcome measures

Outcome measures
Measure	EFLA400 n=36 Participants Oral intake EFLA400(960mg/day) for 12weeks.	Placebo n=37 Participants Oral intake placebo(960mg/day) for 12weeks.
Changes in EF(Erectile Function) Domain Pre	11.53 Scores on a scale Standard Deviation 4.33	12.89 Scores on a scale Standard Deviation 4.19
Changes in EF(Erectile Function) Domain Post	14.56 Scores on a scale Standard Deviation 4.92	16.46 Scores on a scale Standard Deviation 5.16

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

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.

Outcome measures

Outcome measures
Measure	EFLA400 n=36 Participants Oral intake EFLA400(960mg/day) for 12weeks.	Placebo n=37 Participants Oral intake placebo(960mg/day) for 12weeks.
Changes in MSHQ (Male Sexual Health Questionnaire) Pre	70.28 Scores on a scale Standard Deviation 12.98	71.62 Scores on a scale Standard Deviation 14.80
Changes in MSHQ (Male Sexual Health Questionnaire) Post	82.22 Scores on a scale Standard Deviation 17.34	83.81 Scores on a scale Standard Deviation 19.19

SECONDARY outcome

Timeframe: after 12weeks of consumption

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

uroflowmetry(max flow rate) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	EFLA400 n=36 Participants Oral intake EFLA400(960mg/day) for 12weeks.	Placebo n=37 Participants Oral intake placebo(960mg/day) for 12weeks.
Changes in Uroflowmetry(Max Flow Rate) Pre	19.65 m/sec Standard Deviation 9.48	17.64 m/sec Standard Deviation 6.47
Changes in Uroflowmetry(Max Flow Rate) Post	20.63 m/sec Standard Deviation 8.96	20.95 m/sec Standard Deviation 9.46

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

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.

Outcome measures

Outcome measures
Measure	EFLA400 n=36 Participants Oral intake EFLA400(960mg/day) for 12weeks.	Placebo n=37 Participants Oral intake placebo(960mg/day) for 12weeks.
Changes in IIEF(International Index of Erectile Function)-Total Domain Pre	37.83 Scores on a scale Standard Deviation 10.89	41.00 Scores on a scale Standard Deviation 10.30
Changes in IIEF(International Index of Erectile Function)-Total Domain Post	47.11 Scores on a scale Standard Deviation 12.04	50.41 Scores on a scale Standard Deviation 12.58

Adverse Events

EFLA400(960mg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo(960mg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jong-Kwan Park, MD

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Phone: 82-63-276-8284

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place