Maca Extract in Sexual Dysfunction Male

Sexual Dysfunction Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05891327
• Other study ID #: N202303063
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: Taipei Medical University
• Contact: Ming Ta Yang, Doctorate
• Phone: 886-2-27361661
• Email: yangrugby[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sexual Dysfunction Male

Intervention

Dietary Supplement:
• Maca
2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks
• Placebo
Placebo

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IIEF-5 score		Baseline (before supplementation)
Primary	IIEF-5 score		6 weeks of supplementation
Primary	IIEF-5 score		12 weeks of supplementation
Primary	IIEF-5 score		18 weeks of supplementation
Primary	IIEF-5 score		24 weeks of supplementation
Primary	EHS score		Baseline (before supplementation)
Primary	EHS score		6 weeks of supplementation
Primary	EHS score		12 weeks of supplementation
Primary	EHS score		18 weeks of supplementation
Primary	EHS score		24 weeks of supplementation
Primary	level of PSA		Baseline (before supplementation)
Primary	level of PSA		6 weeks of supplementation
Primary	level of PSA		12 weeks of supplementation
Primary	level of PSA		18 weeks of supplementation
Primary	level of PSA		24 weeks of supplementation
Primary	Testosterone level		Baseline (before supplementation)
Primary	Testosterone level		6 weeks of supplementation
Primary	Testosterone level		12 weeks of supplementation
Primary	Testosterone level		18 weeks of supplementation
Primary	Testosterone level		24 weeks of supplementation
Primary	LH level		Baseline (before supplementation)
Primary	LH level		6 weeks of supplementation
Primary	LH level		12 weeks of supplementation
Primary	LH level		18 weeks of supplementation
Primary	LH level		24 weeks of supplementation
Primary	Level of FSH		Baseline (before supplementation)
Primary	Level of FSH		6 weeks of supplementation
Primary	Level of FSH		12 weeks of supplementation
Primary	Level of FSH		18 weeks of supplementation
Primary	Level of FSH		24 weeks of supplementation