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

April 27, 2022 updated by: Natural Wellness Egypt

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sexual health is fundamental to the physical and emotional health and wellbeing of individuals, couples and families, and to the social and economic development of communities and countries" says the World Health Organization. Erectile dysfunction (ED) is defined as the inability to achieve and maintain a penile erection adequate for satisfactory sexual intercourse. ED may affect physical and psychosocial health and may have a significant impact on the quality of life (QoL) of sufferers and their partners. It is a common cross-cultural condition in developing and industrialized countries, but its true incidence is probably underestimated owing to the embarrassment of seeking help.

Data from the Massachusetts Male Aging Study (MMAS), a community based, random sample prospective observational survey of non-institutionalized men aged 40-70years, found that 52% of men reported erectile dysfunction. ED is commonly classified into three categories based on its etiology. These include organic, psychogenic and mixed ED. However, this classification should be used with caution since most cases are actually of mixed etiology. It is therefore suggested to use the term primary organic or primary psychogenic. Phosphodiesterase type 5 inhibitors are the standard care and treatment for most mild to moderate ED patients. Most common side effects of phosphodiesterase-5 inhibitors are in the form of headache, visual abnormalities, nasal congestion, dyspepsia, and myalgia.

Enhancing healthy sexuality is possible with the use of natural plants and nutrients. In Asia, men consider herbal medicine to be a reliable treatment for improving overall wellbeing, including sexual wellbeing.

In Malaysia the root of Eurycoma longifolia, known traditionally as Tongkat Ali, is one of the most popular herbs used for well-being. It is used to increase fertility and sexual power and is claimed to improve strength and power during sexual activities. Many studies carried out on rats and mice have found that administration of E. longifolia extracts increases the sexual arousal and motivation and frequency of sexual activity. These effects are similar to those caused by administration of testosterone, although the effect of Tongkat Ali is not as strong. Tongkat Ali is reputed to increase testosterone effect. It was found to have androgenic effects in male rats, either directly or indirectly, such as increasing the weight of sexual accessories. The effect of this plant is dependent upon the dose; whether or not it contributes significantly to the aphrodisiac qualities of Tongkat ali can only be established with more research.

A recent systematic review with meta-analysis concluded that the herbal extract of Tongkat Ali may have clinical effect on erectile function. However, more efficacy trials are warranted to further support current evidence.

Maca (Lepidium meyenii) is an Andean plant that belongs to the brasslike (mustard) family. It has been used for centuries in enhancing the fertility in humans and animals. Preparations from the Maca root have been reported to improve sexual function in healthy populations. There is a hypothesis questioning if Maca is effective in improving sexual function. Spermatogenic and fertility-enhancing activities are suggested through animal experiments. Some in-vivo studies have shown that Maca may improve sexual behavior and enhance androgen-like effects in rats. Recent clinical trials have also suggested significant effects of Maca for increasing sperm count and mobility and improving sexual function in humans.

However, these data are insufficient for determining whether Maca is clinically effective.

The results of a recent systematic review provide suggestive evidence for the effectiveness of Maca in improving semen quality.

By today, robust clinical data on Tongka tali and Maca safety and efficacy is not sufficient. This study was conducted to evaluate Efficacy and Safety of Tongkat Ali Maca Plus for the improvement of sexual well-being and quality of life in men with mild to moderate erectile dysfunction.

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Menoufia
      • Shibīn Al Kawm, Menoufia, Egypt
        • Faculty of Medicine, Menoufia University/ Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Placebo Comparator: Placebo (starch) in 3 capsules size 1 (0 mg of active ingredient)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natural Wellness Egypt

Investigators

  • Principal Investigator: Prof Dr. Mohamed badreldin, MD, Menoufia University/ Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2019

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TongMac 19052016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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