Maca Extract in Sexual Dysfunction Male

Not Applicable

Not yet recruiting

• Conditions: Sexual Dysfunction Male
• Interventions: Dietary Supplement: Maca; Dietary Supplement: Placebo

• Registration Number: NCT05891327
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-06
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12
• Study Start: 2023-12
• Primary Completion: 2024-04
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maca group	Maca	-
Placebo group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Testosterone level	24 weeks of supplementation
LH level	24 weeks of supplementation
Level of FSH	24 weeks of supplementation
IIEF-5 score	24 weeks of supplementation
EHS score	24 weeks of supplementation
level of PSA	24 weeks of supplementation

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan