Erectile DysfunctionNCT05347329
A Clinical Trial to Investigate the Efficacy and Safety of Tongkat Ali Maca Plus
A study testing Tongkat Ali Maca Plus in people with Erectile Dysfunction, run by Natural Wellness Egypt at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Tongkat Ali Maca Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2019to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male aged between 35 and 65 years.
- 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.
- Patients with decreased libido according to self-report.
- 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.
- Patients willing to stop any other medications for erectile dysfunction throughout study duration.
- Able and willing to provide written informed consent
Who cannot join
- Patients with history of prostate cancer
- Patients with free: total prostate-specific antigen (PSA) ratio ≤ 0.15 or PSA > 4 ng/ml.
- Patients with acute or chronic prostatitis during the screening visit.
- Patients with Penile anatomical abnormalities
- Patients with pregnant partners or partners planning to become pregnant during the study.
- Clinically significant abnormality of physical examination that from investigator's point of view may interfere with study treatment.
Show all 23Show fewer
- Any medical or psychological condition or social circumstances that would impair subject's ability to participate reliably in the study.
- Testosterone implant during 6 months prior to screening.
- Subjects for whom sexual activity is inadvisable.
- Uncontrolled hypertension according to ESC/ESH guidelines.
- Uncontrolled hypotension as defined by average SBP < 90 mmHg or average DBP <60 mmHg.
- Uncontrolled diabetes mellitus as defined by HbA1c ≥ 7%.
- Alcohol or substance abuse or dependence within the past six months.
- Recent major relationship changes, disruption, or turmoil
- Patients with any major psychiatric disorder (including major depression or schizophrenia).
- 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.
- Consumption of medications which may alter sexual performances e.g., intake of hormone therapy, anti-depressants, H2 blockers, nitrates, anti- androgens or chemotherapy.
- Patients with Allergy or allergic history to any of the drug components.
- Patients with history of HIV infection or current infection with any sexually transmitted diseases.
- Receipt of an investigational drug within 6 months prior to screening, or active enrolment in another investigational medication or device trial.
- Patients with any chronic illness or prior treatment which in the opinion of the investigator should preclude participation in the trial.
- Inability to understand and cooperate with the investigators or to give valid consent.
- Patients with BMI > 40 Kg/m2 or BMI < 18.5 Kg/m2.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Menoufia University/ Egypt
Shibīn al Kawm, Menoufia
About this study
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
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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Tongkat Ali Maca Plus
- Keywords
- Tongkat Ali and Maca
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongkat Ali Maca PlusDietary supplement
Also called Placebo Comparator: Placebo (starch) in 3 capsules size 1 (0 mg of active ingredient)
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Arm 1 | Placebo comparator | Placebo (starch) in 3 capsules size 1 (0 mg of active ingredient), administered orally once daily on empty stomach with plenty of water. Receives: Dietary Supplement: Tongkat Ali Maca Plus |
| 400 mg Tongkat Ali+ 200 mg Maca (Experimental Arm 2) | Experimental | 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. Receives: Dietary Supplement: Tongkat Ali Maca Plus |
| 600 mg Tongkat Ali+ 300 mg Maca ( Experimental Arm 3) | Experimental | 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. Receives: Dietary Supplement: Tongkat Ali Maca Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the effect of Tongkat Ali and Maca dried roots extracts (Tongkat Ali Maca Plus) on sexual performance
sexual performance will be measured by the change in the International Index of Erectile Function questionnaire score
Measured: 12 weeks
To explore the safety of Tongkat Ali Maca Plus as measured by the occurrence of adverse events
the safety of Tongkat Ali Maca Plus will be measured by the occurrence of adverse events
Measured: 12 weeks
Secondary outcomes (3)
To explore the effect of Tongkat Ali Maca Plus on serum levels of free and total testosterone.
To explore the effect of Tongkat Ali Maca Plus on serum levels of free and total testosterone.
Measured: 12 weeks
To explore the effect of Tongkat Ali Maca Plus on sexual wellbeing
sexual wellbeing will be measured by the change in Erectile Dysfunction Effect on Quality of Life questionnaire score
Measured: 12 weeks
To explore the effect of Tongkat Ali Maca Plus on quality of life
quality of life measured by the change in World Health Organization Quality-of-Life Scale questionnaire score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start10 Sep 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Wellness Egypt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof Dr. Mohamed badreldin, MD, Principal investigator, Menoufia University/ Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347329
- Sponsor's protocol ID
- TongMac 19052016
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salonia A, Castagna G, Sacca A, Ferrari M, Capitanio U, Castiglione F, Rocchini L, Briganti A, Rigatti P, Montorsi F. Is erectile dysfunction a reliable proxy of general male health status? The case for the International Index of Erectile Function-Erectile Function domain. J Sex Med. 2012 Oct;9(10):2708-15. doi: 10.1111/j.1743-6109.2012.02869.x. Epub 2012 Aug 15.
PubMed 22897643Johannes CB, Araujo AB, Feldman HA, Derby CA, Kleinman KP, McKinlay JB. Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts male aging study. J Urol. 2000 Feb;163(2):460-3.
PubMed 10647654Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
PubMed 8254833Ismail SB, Wan Mohammad WM, George A, Nik Hussain NH, Musthapa Kamal ZM, Liske E. Randomized Clinical Trial on the Use of PHYSTA Freeze-Dried Water Extract of Eurycoma longifolia for the Improvement of Quality of Life and Sexual Well-Being in Men. Evid Based Complement Alternat Med. 2012;2012:429268. doi: 10.1155/2012/429268. Epub 2012 Nov 1.
PubMed 23243445Kotirum S, Ismail SB, Chaiyakunapruk N. Efficacy of Tongkat Ali (Eurycoma longifolia) on erectile function improvement: systematic review and meta-analysis of randomized controlled trials. Complement Ther Med. 2015 Oct;23(5):693-8. doi: 10.1016/j.ctim.2015.07.009. Epub 2015 Jul 31.
PubMed 26365449Gonzales GF. Ethnobiology and Ethnopharmacology of Lepidium meyenii (Maca), a Plant from the Peruvian Highlands. Evid Based Complement Alternat Med. 2012;2012:193496. doi: 10.1155/2012/193496. Epub 2011 Oct 2.
PubMed 21977053Lee MS, Lee HW, You S, Ha KT. The use of maca (Lepidium meyenii) to improve semen quality: A systematic review. Maturitas. 2016 Oct;92:64-69. doi: 10.1016/j.maturitas.2016.07.013. Epub 2016 Jul 21.
PubMed 27621241Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. N Engl J Med. 1998 May 14;338(20):1397-404. doi: 10.1056/NEJM199805143382001.
PubMed 9580646Meuleman E, Cuzin B, Opsomer RJ, Hartmann U, Bailey MJ, Maytom MC, Smith MD, Osterloh IH. A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction. BJU Int. 2001 Jan;87(1):75-81. doi: 10.1046/j.1464-410x.2001.00998.x.
PubMed 11121996Tan HM, Moh CL, Mendoza JB, Gana T, Albano GJ, de la Cruz R, Chye PL, Sam CC. Asian sildenafil efficacy and safety study (ASSESS-1): a double-blind, placebo-controlled, flexible-dose study of oral sildenafil in Malaysian, Singaporean, and Filipino men with erectile dysfunction. The Assess-1 Study Group. Urology. 2000 Oct 1;56(4):635-40. doi: 10.1016/s0090-4295(00)00688-9.
PubMed 11018621Zenico T, Cicero AF, Valmorri L, Mercuriali M, Bercovich E. Subjective effects of Lepidium meyenii (Maca) extract on well-being and sexual performances in patients with mild erectile dysfunction: a randomised, double-blind clinical trial. Andrologia. 2009 Apr;41(2):95-9. doi: 10.1111/j.1439-0272.2008.00892.x.
PubMed 19260845Tambi MI, Imran MK, Henkel RR. Standardised water-soluble extract of Eurycoma longifolia, Tongkat ali, as testosterone booster for managing men with late-onset hypogonadism? Andrologia. 2012 May;44 Suppl 1:226-30. doi: 10.1111/j.1439-0272.2011.01168.x. Epub 2011 Jun 15.
PubMed 21671978
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05347329
- Acronym / sponsor ID
- TongMac 19052016
- Conditions
- Erectile Dysfunction
- Keywords
- Tongkat Ali and Maca
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Natural Wellness EgyptIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Arm 1 | Placebo comparator | Dietary Supplement: Tongkat Ali Maca PlusPlacebo (starch) in 3 capsules size 1 (0 mg of active ingredient), administered orally once daily on empty stomach with plenty of water. |
| 400 mg Tongkat Ali+ 200 mg Maca (Experimental Arm 2) | Experimental | Dietary Supplement: Tongkat Ali Maca PlusThe 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. |
| 600 mg Tongkat Ali+ 300 mg Maca ( Experimental Arm 3) | Experimental | Dietary Supplement: Tongkat Ali Maca PlusThe 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male aged between 35 and 65 years.
- 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.
- Patients with decreased libido according to self-report.
- 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.
- Patients willing to stop any other medications for erectile dysfunction throughout study duration.
Key exclusion criteria (23 listed)
- Patients with history of prostate cancer
- Patients with free: total prostate-specific antigen (PSA) ratio ≤ 0.15 or PSA > 4 ng/ml.
- Patients with acute or chronic prostatitis during the screening visit.
- Patients with Penile anatomical abnormalities
- Patients with pregnant partners or partners planning to become pregnant during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongkat Ali Maca PlusAlso: Placebo Comparator: Placebo (starch) in 3 capsules size 1 (0 mg of active ingredient)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). | Dietary supplement | 400 mg Tongkat Ali+ 200 mg Maca (Experimental Arm 2), 600 mg Tongkat Ali+ 300 mg Maca ( Experimental Arm 3), Control Arm 1 |
Primary outcome
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
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
3 secondary outcomes
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 sexual wellbeing
Time frame: 12 weeks
To explore the effect of Tongkat Ali Maca Plus on quality of life
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Background: PubMed 22897643Salonia A, Castagna G, Sacca A, Ferrari M, Capitanio U, Castiglione F, Rocchini L, Briganti A, Rigatti P, Montorsi F. Is erectile dysfunction a reliable proxy of general male health status? The case for the International Index of Erectile Function-Erectile Function domain. J Sex Med. 2012 Oct;9(10):2708-15. doi: 10.1111/j.1743-6109.2012.02869.x. Epub 2012 Aug 15.
- Background: PubMed 10647654Johannes CB, Araujo AB, Feldman HA, Derby CA, Kleinman KP, McKinlay JB. Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts male aging study. J Urol. 2000 Feb;163(2):460-3.
- Background: PubMed 8254833Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
- Background: PubMed 23243445Ismail SB, Wan Mohammad WM, George A, Nik Hussain NH, Musthapa Kamal ZM, Liske E. Randomized Clinical Trial on the Use of PHYSTA Freeze-Dried Water Extract of Eurycoma longifolia for the Improvement of Quality of Life and Sexual Well-Being in Men. Evid Based Complement Alternat Med. 2012;2012:429268. doi: 10.1155/2012/429268. Epub 2012 Nov 1.
- Background: PubMed 26365449Kotirum S, Ismail SB, Chaiyakunapruk N. Efficacy of Tongkat Ali (Eurycoma longifolia) on erectile function improvement: systematic review and meta-analysis of randomized controlled trials. Complement Ther Med. 2015 Oct;23(5):693-8. doi: 10.1016/j.ctim.2015.07.009. Epub 2015 Jul 31.
- Background: PubMed 21977053Gonzales GF. Ethnobiology and Ethnopharmacology of Lepidium meyenii (Maca), a Plant from the Peruvian Highlands. Evid Based Complement Alternat Med. 2012;2012:193496. doi: 10.1155/2012/193496. Epub 2011 Oct 2.
- Background: PubMed 27621241Lee MS, Lee HW, You S, Ha KT. The use of maca (Lepidium meyenii) to improve semen quality: A systematic review. Maturitas. 2016 Oct;92:64-69. doi: 10.1016/j.maturitas.2016.07.013. Epub 2016 Jul 21.
- Background: PubMed 9580646Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. N Engl J Med. 1998 May 14;338(20):1397-404. doi: 10.1056/NEJM199805143382001.
- Background: PubMed 11121996Meuleman E, Cuzin B, Opsomer RJ, Hartmann U, Bailey MJ, Maytom MC, Smith MD, Osterloh IH. A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction. BJU Int. 2001 Jan;87(1):75-81. doi: 10.1046/j.1464-410x.2001.00998.x.
- Background: PubMed 11018621Tan HM, Moh CL, Mendoza JB, Gana T, Albano GJ, de la Cruz R, Chye PL, Sam CC. Asian sildenafil efficacy and safety study (ASSESS-1): a double-blind, placebo-controlled, flexible-dose study of oral sildenafil in Malaysian, Singaporean, and Filipino men with erectile dysfunction. The Assess-1 Study Group. Urology. 2000 Oct 1;56(4):635-40. doi: 10.1016/s0090-4295(00)00688-9.
- Background: PubMed 19260845Zenico T, Cicero AF, Valmorri L, Mercuriali M, Bercovich E. Subjective effects of Lepidium meyenii (Maca) extract on well-being and sexual performances in patients with mild erectile dysfunction: a randomised, double-blind clinical trial. Andrologia. 2009 Apr;41(2):95-9. doi: 10.1111/j.1439-0272.2008.00892.x.
- Background: PubMed 21671978Tambi MI, Imran MK, Henkel RR. Standardised water-soluble extract of Eurycoma longifolia, Tongkat ali, as testosterone booster for managing men with late-onset hypogonadism? Andrologia. 2012 May;44 Suppl 1:226-30. doi: 10.1111/j.1439-0272.2011.01168.x. Epub 2011 Jun 15.
- Individual participant dataSharing planned: No
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Erectile Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Dr. Mohamed badreldin, MD principal investigator
Menoufia University/ Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongkat Ali Maca Plus in people with Erectile Dysfunction, run by Natural Wellness Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore the effect of Tongkat Ali and Maca dried roots extracts (Tongkat Ali Maca Plus) on sexual performance (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05347329, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.