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A Clinical Trial to Investigate the Efficacy and Safety of Tongkat Ali Maca Plus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05347329
Recruitment Status : Completed
First Posted : April 26, 2022
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
Natural Wellness Egypt

Brief Summary:
This was a randomized, double blind, placebo-controlled, Three-arm, multicenter, parallel groups, interventional phase II clinical trial evaluating the efficacy, and safety of a herbal medicinal product of dried roots of Eurycoma longifolia Jack (Tongkat Ali) and dried tuberous roots of Lepidium meyenii (Maca) for the improvement of sexual well-being and quality of life in men.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Dietary Supplement: Tongkat Ali Maca Plus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This was a randomized, double blind, placebo-controlled, Three-arm, multicenter, parallel groups, interventional phase II clinical trial evaluating the efficacy, and safety of a herbal medicinal product of dried roots of Eurycoma longifolia Jack (Tongkat Ali) and dried tuberous roots of Lepidium meyenii (Maca) for the improvement of sexual well-being and quality of life in men.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The arms randomization was performed using Interactive web response system (IWRS).
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double Blind, Placebo-Controlled, Three-arm, Multi-center Clinical Trial to Investigate the Efficacy and Safety of Tongkat Ali Maca Plus for the Improvement of Sexual Well-being and Quality of Life in Men
Actual Study Start Date : September 10, 2019
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Arm 1
Placebo (starch) in 3 capsules size 1 (0 mg of active ingredient), administered orally once daily on empty stomach with plenty of water.
Dietary Supplement: Tongkat Ali Maca Plus
Tongkat Ali and Maca (Tongkat Ali: powdered extract 200 mg (from roots of Eurycoma longifolia Jack) + Maca: powdered extract 100 mg (from dried tuberous root of Lepidium meyenii).
Other Name: Placebo Comparator: Placebo (starch) in 3 capsules size 1 (0 mg of active ingredient)

Experimental: 400 mg Tongkat Ali+ 200 mg Maca (Experimental Arm 2)
The content of 2 capsules of Tongkat Ali Maca (600 mg of active ingredient), Plus is equally distributed and inserted into 3 capsules size 1 (low dose), administered orally once daily with plenty of water.
Dietary Supplement: Tongkat Ali Maca Plus
Tongkat Ali and Maca (Tongkat Ali: powdered extract 200 mg (from roots of Eurycoma longifolia Jack) + Maca: powdered extract 100 mg (from dried tuberous root of Lepidium meyenii).
Other Name: Placebo Comparator: Placebo (starch) in 3 capsules size 1 (0 mg of active ingredient)

Experimental: 600 mg Tongkat Ali+ 300 mg Maca ( Experimental Arm 3)
The content of 3 capsules of Tongkat Ali Maca Plus (900 mg of active ingredient), is equally distributed and inserted into 3 capsules size 1 (high dose), administered orally once daily with plenty of water.
Dietary Supplement: Tongkat Ali Maca Plus
Tongkat Ali and Maca (Tongkat Ali: powdered extract 200 mg (from roots of Eurycoma longifolia Jack) + Maca: powdered extract 100 mg (from dried tuberous root of Lepidium meyenii).
Other Name: Placebo Comparator: Placebo (starch) in 3 capsules size 1 (0 mg of active ingredient)




Primary Outcome Measures :
  1. To explore the effect of Tongkat Ali and Maca dried roots extracts (Tongkat Ali Maca Plus) on sexual performance [ Time Frame: 12 weeks ]
    sexual performance will be measured by the change in the International Index of Erectile Function questionnaire score

  2. To explore the safety of Tongkat Ali Maca Plus as measured by the occurrence of adverse events [ Time Frame: 12 weeks ]
    the safety of Tongkat Ali Maca Plus will be measured by the occurrence of adverse events


Secondary Outcome Measures :
  1. To explore the effect of Tongkat Ali Maca Plus on serum levels of free and total testosterone. [ Time Frame: 12 weeks ]
    To explore the effect of Tongkat Ali Maca Plus on serum levels of free and total testosterone.

  2. To explore the effect of Tongkat Ali Maca Plus on sexual wellbeing [ Time Frame: 12 weeks ]
    sexual wellbeing will be measured by the change in Erectile Dysfunction Effect on Quality of Life questionnaire score

  3. To explore the effect of Tongkat Ali Maca Plus on quality of life [ Time Frame: 12 weeks ]
    quality of life measured by the change in World Health Organization Quality-of-Life Scale questionnaire score



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male aged between 35 and 65 years.
  2. Patients with mild, mild to moderate or moderate Erectile Dysfunction as defined by International Index of Erectile Function-5 (IIEF-5) score ≥8 and ≤21.
  3. Patients with decreased libido according to self-report.
  4. Patients in a stable heterosexual relationship for at least 6 months and willing to continue efforts at sexual activity for the duration of the study.
  5. Patients willing to stop any other medications for erectile dysfunction throughout study duration.
  6. Able and willing to provide written informed consent

Exclusion Criteria:

  1. Patients with history of prostate cancer
  2. Patients with free: total prostate-specific antigen (PSA) ratio ≤ 0.15 or PSA > 4 ng/ml.
  3. Patients with acute or chronic prostatitis during the screening visit.
  4. Patients with Penile anatomical abnormalities
  5. Patients with pregnant partners or partners planning to become pregnant during the study.
  6. Clinically significant abnormality of physical examination that from investigator's point of view may interfere with study treatment.
  7. Any medical or psychological condition or social circumstances that would impair subject's ability to participate reliably in the study.
  8. Testosterone implant during 6 months prior to screening.
  9. Subjects for whom sexual activity is inadvisable.
  10. Uncontrolled hypertension according to ESC/ESH guidelines.
  11. Uncontrolled hypotension as defined by average SBP < 90 mmHg or average DBP <60 mmHg.
  12. Uncontrolled diabetes mellitus as defined by HbA1c ≥ 7%.
  13. Alcohol or substance abuse or dependence within the past six months.
  14. Recent major relationship changes, disruption, or turmoil
  15. Patients with any major psychiatric disorder (including major depression or schizophrenia).
  16. Patients with a history of medical conditions or procedures which may cause sexual dysfunction, including: heart failure, serious psychiatric diseases, endocrinological diseases, active cardiovascular diseases, peripheral vascular disease, spinal cord injury, pelvic fracture, brain injuries or tumors, multiple sclerosis.
  17. Consumption of medications which may alter sexual performances e.g., intake of hormone therapy, anti-depressants, H2 blockers, nitrates, anti- androgens or chemotherapy.
  18. Patients with Allergy or allergic history to any of the drug components.
  19. Patients with history of HIV infection or current infection with any sexually transmitted diseases.
  20. Receipt of an investigational drug within 6 months prior to screening, or active enrolment in another investigational medication or device trial.
  21. Patients with any chronic illness or prior treatment which in the opinion of the investigator should preclude participation in the trial.
  22. Inability to understand and cooperate with the investigators or to give valid consent.
  23. Patients with BMI > 40 Kg/m2 or BMI < 18.5 Kg/m2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05347329


Locations
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Egypt
Faculty of Medicine, Menoufia University/ Egypt
Shibīn Al Kawm, Menoufia, Egypt
Sponsors and Collaborators
Natural Wellness Egypt
Investigators
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Principal Investigator: Prof Dr. Mohamed badreldin, MD Menoufia University/ Egypt
Publications:

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Responsible Party: Natural Wellness Egypt
ClinicalTrials.gov Identifier: NCT05347329    
Other Study ID Numbers: TongMac 19052016
First Posted: April 26, 2022    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Natural Wellness Egypt:
Tongkat Ali and Maca
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders