A Clinical Trial to Investigate the Efficacy and Safety of Tongkat Ali Maca Plus
Erectile Dysfunction
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Tongkat Ali and Maca
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Faculty of Medicine, Menoufia University/ Egypt
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Control Arm 1
400 mg Tongkat Ali+ 200 mg Maca (Experimental Arm 2)
600 mg Tongkat Ali+ 300 mg Maca ( Experimental Arm 3)
Placebo (starch) in 3 capsules size 1 (0 mg of active ingredient), administered orally once daily on empty stomach with plenty of water.
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.
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.