None listed
Conditions
Brief summary
The aim of the study is to assess the herbal formulation in reducing the symptoms of andropause and influencing serum testosterone levels. The inadequate production of testosterone in men as they age has been associated with Andropause, a variable complex of symptoms, including decreased androgen production, occurring in men after middle age. Andropause has an obvious effect on male sexual health, but may also affect general health in men as they age. The key features of Andropause include: Lethargy and fatigue Diminished sexual desire/libido Increased abdominal fat (waist circumference greater than 102cm) Depressed mood or irritability Decreased cognitive function Hot flushes or sweating Decreased lean body mass and muscle volume/strength Decreased body hair and skin alterations Low bone mineral density or increased incidence of fractures Sleep disturbance
Interventions
Capsules, 2/day, Oral administration for 8 weeks
Formula: Per capsule: Trigonella foenum-graecum (Fenugreek/Testofen) seed extract, 300mg, gelatin, maltodextrin
Daily Dose: 600 mg Fenugreek
Sponsors
AZPA International
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Heterosexual male aged between 45-75 Otherwise healthy Written informed consent from the subject
Exclusion criteria
Subjects will be excluded for any one of the following reasons: Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion Known hypersensitivity to herbal drugs/nutritional supplement/ foods Any physical disability that may limit sexual function or erectile dysfunction Received any treatment/therapy I(including testosterone) for any sexual disorder during last 6 months Receiving/ prescribed coumandin (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