Maca Extract in Sexual Dysfunction Male

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

Detailed Description
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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.

Official Title
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Effects of Lepidium Meyenii (Maca) Extract Supplementation on Male Sexual Funtion

Conditions
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Sexual Dysfunction Male

Intervention / Treatment
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* Dietary Supplement: Maca
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: evaluated as sexual dysfunction for more than three months by physician international index of erectile function (IIEF) score is less than or equal to 21 erectile hardness score (EHS) score is less than or equal to 3 aged over 18 years old Exclusion Criteria: unable to cooperate with the course of the treatment suffering from sexually transmitted diseases such as Syphilis, AIDS and HPVs had Radical Prostatectomy (total removal of the prostate gland) suffering from active tumors in the prostate or pelvic area suffering from Hypogonadism anatomical deformation of the penis men with penile prosthesis suffering from psychotic disorder (manic disorder, chronic depression, etc.) suffering from neurological diseases (multiple sclerosis, brain or spinal cord injuries, etc.) using Permanent pacemaker considered unsuitable to participate in this experiment according to the doctor alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: assign 60 participants into the experimental group (n = 30) or placebo group (n = 30)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maca group<br> | Dietary Supplement: Maca<br>* 2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks<br>|
| Placebo Comparator: Placebo group<br> | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF-5 score |  | Baseline (before supplementation) | 
| IIEF-5 score |  | 6 weeks of supplementation | 
| IIEF-5 score |  | 12 weeks of supplementation | 
| IIEF-5 score |  | 18 weeks of supplementation | 
| IIEF-5 score |  | 24 weeks of supplementation | 
| EHS score |  | Baseline (before supplementation) | 
| EHS score |  | 6 weeks of supplementation | 
| EHS score |  | 12 weeks of supplementation | 
| EHS score |  | 18 weeks of supplementation | 
| EHS score |  | 24 weeks of supplementation | 
| level of PSA |  | Baseline (before supplementation) | 
| level of PSA |  | 6 weeks of supplementation | 
| level of PSA |  | 12 weeks of supplementation | 
| level of PSA |  | 18 weeks of supplementation | 
| level of PSA |  | 24 weeks of supplementation | 
| Testosterone level |  | Baseline (before supplementation) | 
| Testosterone level |  | 6 weeks of supplementation | 
| Testosterone level |  | 12 weeks of supplementation | 
| Testosterone level |  | 18 weeks of supplementation | 
| Testosterone level |  | 24 weeks of supplementation | 
| LH level |  | Baseline (before supplementation) | 
| LH level |  | 6 weeks of supplementation | 
| LH level |  | 12 weeks of supplementation | 
| LH level |  | 18 weeks of supplementation | 
| LH level |  | 24 weeks of supplementation | 
| Level of FSH |  | Baseline (before supplementation) | 
| Level of FSH |  | 6 weeks of supplementation | 
| Level of FSH |  | 12 weeks of supplementation | 
| Level of FSH |  | 18 weeks of supplementation | 
| Level of FSH |  | 24 weeks of supplementation |