Maca Extract in Sexual Dysfunction Male

NCT ID: NCT05891327

Last Updated: 2023-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-05-31

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.

Conditions

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Sexual Dysfunction Male

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

assign 60 participants into the experimental group (n = 30) or placebo group (n = 30)
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
A double-blind, matched-pair study design

Study Groups

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Maca group

Group Type EXPERIMENTAL

Maca

Intervention Type DIETARY_SUPPLEMENT

2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Maca

2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Medical University

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Ming Ta Yang, Doctorate

Role: CONTACT

886-2-27361661 ext. 2275

Other Identifiers

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N202303063

Identifier Type: -

Identifier Source: org_study_id

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