None listed
Conditions
Brief summary
This trial is being undertaken to assess whether the herbal formulation containing Testofen improves general sexual function, performance, and satisfaction in healthy males.
Interventions
Tablet-form herbal formulation containing Trigonella foenum-graecum seed extract (equivalent to 9900 mg), magnesium aspartate (equivalent to Mg 15.17 mg), zinc amino acid chelate (equivalent to Zn 15 mg) and vitamin B6 (equivalent to pyridoxine 4.94 mg).
Dosing is one tablet, twice per day, by-mouth: one hour before the morning meal (breakfast) and one hour before the evening meal (dinner) for a total of 2 tablets per day, for the duration of the trial (6 weeks).
Sponsors
AZPA International
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
25 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Heterosexual; Stable sexual relationship for at least the last 6 months; Sexually active for at least the last 6 months; Anticipated stable sexual relationship for at least the next 8 weeks; Sexual partner willing to provide information during interviews; Written informed consent from the subject.
Exclusion criteria
Homosexual orientation; Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion; Known hypersensitivity to herbal drugs/nutritional supplement/ foods; Possible physical unavailability of sexual partner during trial period; Any physical disability that may limit sexual function; Received any treatment/therapy for any sexual disorder during last 6 months; Receiving/ prescribed coumadin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy; Receiving/ prescribed levodopa (Sinemet) for Parkinson’s Disease or calcipotriene (Dovonex) for Psoriasis; Diagnosed with hypertension and receiving/ prescribed antihypertensive medications; Diagnosed severe renal and/or hepatic insufficiency; Diagnosed genital anatomical deformities, uncontrolled diabetes mellitus, and history of spinal cord injury, uncontrolled psychiatric disorder, and/or abnormal secondary sexual characteristics; Diagnosed prostatic cancer or benign hypertrophy; if suspected by the investigator, refer for medical assessment; Acute genitourinary disorder; History of genital surgery; Current or history of chronic alcohol and/or drug abuse; Suspected or diagnosed chickpea allergy; Participation in any other clinical trial during last 30 days; Simultaneous participation in another clinical trial.
Outcome results
None listed