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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05891327
Other study ID # N202303063
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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