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Maca Extract in Sexual Dysfunction Male

Sponsor
Taipei Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05891327
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Maca
  • Dietary Supplement: Placebo
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
assign 60 participants into the experimental group (n = 30) or placebo group (n = 30)assign 60 participants into the experimental group (n = 30) or placebo group (n = 30)
Masking:
Double (Participant, Investigator)
Masking Description:
A double-blind, matched-pair study design
Primary Purpose:
Treatment
Official Title:
Effects of Lepidium Meyenii (Maca) Extract Supplementation on Male Sexual Funtion
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Maca group

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

Dietary Supplement: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. IIEF-5 score [Baseline (before supplementation)]

  2. IIEF-5 score [6 weeks of supplementation]

  3. IIEF-5 score [12 weeks of supplementation]

  4. IIEF-5 score [18 weeks of supplementation]

  5. IIEF-5 score [24 weeks of supplementation]

  6. EHS score [Baseline (before supplementation)]

  7. EHS score [6 weeks of supplementation]

  8. EHS score [12 weeks of supplementation]

  9. EHS score [18 weeks of supplementation]

  10. EHS score [24 weeks of supplementation]

  11. level of PSA [Baseline (before supplementation)]

  12. level of PSA [6 weeks of supplementation]

  13. level of PSA [12 weeks of supplementation]

  14. level of PSA [18 weeks of supplementation]

  15. level of PSA [24 weeks of supplementation]

  16. Testosterone level [Baseline (before supplementation)]

  17. Testosterone level [6 weeks of supplementation]

  18. Testosterone level [12 weeks of supplementation]

  19. Testosterone level [18 weeks of supplementation]

  20. Testosterone level [24 weeks of supplementation]

  21. LH level [Baseline (before supplementation)]

  22. LH level [6 weeks of supplementation]

  23. LH level [12 weeks of supplementation]

  24. LH level [18 weeks of supplementation]

  25. LH level [24 weeks of supplementation]

  26. Level of FSH [Baseline (before supplementation)]

  27. Level of FSH [6 weeks of supplementation]

  28. Level of FSH [12 weeks of supplementation]

  29. Level of FSH [18 weeks of supplementation]

  30. Level of FSH [24 weeks of supplementation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Medical University Taipei Taiwan 110

Sponsors and Collaborators

  • Taipei Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Medical University
ClinicalTrials.gov Identifier:
NCT05891327
Other Study ID Numbers:
  • N202303063
First Posted:
Jun 6, 2023
Last Update Posted:
Jun 6, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 6, 2023