Clinical trial NCT05891327: Maca Extract in Sexual Dysfunction Male
Official title: Effects of Lepidium Meyenii (Maca) Extract Supplementation on Male Sexual Funtion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sexual Dysfunction Male
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: assign 60 participants into the experimental group (n = 30) or placebo group (n = 30)
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effects of Lepidium meyenii (Maca) extract supplementation on male sexual funtion.

Detailed description: All participants performed anthropometric measurements, blood collection and questionnaire survey at 0-week. A random, double-blind design will be used to assign 60 participants into the experimental group (n = 30) or placebo group (n = 30). All participants consumed either 2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks. The anthropometric measurements, blood samples, and questionnaire survey were collected again at 6-week, 12-week, 16-week, and 24-week. Data will be analyzed by two-way mixed design ANOVA.

Eligibility criteria: Inclusion Criteria:

1. evaluated as sexual dysfunction for more than three months by physician
2. international index of erectile function (IIEF) score is less than or equal to 21
3. erectile hardness score (EHS) score is less than or equal to 3
4. aged over 18 years old

Exclusion Criteria:

1. unable to cooperate with the course of the treatment
2. suffering from sexually transmitted diseases such as Syphilis, AIDS and HPVs
3. had Radical Prostatectomy (total removal of the prostate gland)
4. suffering from active tumors in the prostate or pelvic area
5. suffering from Hypogonadism
6. anatomical deformation of the penis
7. men with penile prosthesis
8. suffering from psychotic disorder (manic disorder, chronic depression, etc.)
9. suffering from neurological diseases (multiple sclerosis, brain or spinal cord injuries, etc.)
10. using Permanent pacemaker
11. considered unsuitable to participate in this experiment according to the doctor
12. alcohol or drug abuse

Primary outcomes:
measure: IIEF-5 score
timeFrame: Baseline (before supplementation)
measure: IIEF-5 score
timeFrame: 6 weeks of supplementation
measure: IIEF-5 score
timeFrame: 12 weeks of supplementation
measure: IIEF-5 score
timeFrame: 18 weeks of supplementation
measure: IIEF-5 score
timeFrame: 24 weeks of supplementation
measure: EHS score
timeFrame: Baseline (before supplementation)
measure: EHS score
timeFrame: 6 weeks of supplementation
measure: EHS score
timeFrame: 12 weeks of supplementation
measure: EHS score
timeFrame: 18 weeks of supplementation
measure: EHS score
timeFrame: 24 weeks of supplementation
measure: level of PSA
timeFrame: Baseline (before supplementation)
measure: level of PSA
timeFrame: 6 weeks of supplementation
measure: level of PSA
timeFrame: 12 weeks of supplementation
measure: level of PSA
timeFrame: 18 weeks of supplementation
measure: level of PSA
timeFrame: 24 weeks of supplementation
measure: Testosterone level
timeFrame: Baseline (before supplementation)
measure: Testosterone level
timeFrame: 6 weeks of supplementation
measure: Testosterone level
timeFrame: 12 weeks of supplementation
measure: Testosterone level
timeFrame: 18 weeks of supplementation
measure: Testosterone level
timeFrame: 24 weeks of supplementation
measure: LH level
timeFrame: Baseline (before supplementation)
measure: LH level
timeFrame: 6 weeks of supplementation
measure: LH level
timeFrame: 12 weeks of supplementation
measure: LH level
timeFrame: 18 weeks of supplementation
measure: LH level
timeFrame: 24 weeks of supplementation
measure: Level of FSH
timeFrame: Baseline (before supplementation)
measure: Level of FSH
timeFrame: 6 weeks of supplementation
measure: Level of FSH
timeFrame: 12 weeks of supplementation
measure: Level of FSH
timeFrame: 18 weeks of supplementation
measure: Level of FSH
timeFrame: 24 weeks of supplementation
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
References: