Efficacy Evaluation of Furosap, a Testosterone Booster Supplement in Human Volunteers : An add-on Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- % Change in serum Testosterone levels
研究概览
简要总结
The study evaluates the effect of Fenugreek seed extract (Furosap) in management of symptomatic hypogonadism as fenugreek seed extract is a testosterone booster. Fenugreek seeds extract are known to possess protodioscin and the extract is reported to improve sperm count, sperm morphology and protective effect on male reproductive system. All the participants will receive one capsule (500 mg) of furosap once a day.
详细描述
Testosterone deficiency (hypogonadism) is increasingly recognized as a significant health problem in aging men. Testosterone deficiency can adversely affect sexual function, physical health and psychological health. Consequently, the quality of life of men with low testosterone is negatively affected.
A certain proportion of middle-aged and elderly men have total testosterone concentrations below the reference range for young adult males. Possible consequences of reduced androgen levels include fat mass gain, loss of muscle and bone mass, fatigue, depression, anaemia, poor libido and erectile dysfunction. The clinical features of androgen deficiency in the aging male (ADAM) resemble those of hypogonadism of younger subjects, with a single relevant difference: each of these features can also occur in elderly men with normal androgen levels.
The world Health Organization estimates that by 2025, worldwide, the number of people aged over 65 years will rise from the current figure of 390 million to 800 million. In the Hypogonadism in Males (HIM) study of men treated in the primary care setting, 38.7% of men aged ≥45 years tested positive for hypogonadism (TT <300 ng/dL). Applied to U. S. census data, these findings suggest that 13.8 million American men aged ≥45 years may be testosterone- deficient. Furthermore, the prevalence of testosterone deficiency increases with age, reaching 50% for men aged ≥85 years. As the population ages, the burden of testosterone deficiency is expected to grow. The prevalence of low testosterone also increases in men with common co- morbidities, such as obesity, diabetes, and metabolic syndrome.
The nutritional status with an age is a major determinant of health and fitness. Nutrition plays a central role in adaptation, rehydration, refueling, and repair as well as recovery from injury and other problems. The testosterone supplementation in older men with low testosterone levels may improve the testosterone level which further improve the physical, sexual, and cognitive functions, and improve mood and quality of life
FUROSAP® is an innovative product made through a novel patented process, involving physical separations of active ingredients from the seeds of Fenugreek herb (Trigonella foenum-graecum) without affecting chemical properties of the active fractions. It is a natural and promising dietary supplement. It"s dietary supplement comprising Protodioscin as the major fraction which isolated from fenugreek seeds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Agrees to written as well as audio-visual informed consent.
- •Ability to understand the risks/benefits of the protocol
- •Male between 35-65 years of age.
- •Diagnosed with Symptomatic hypogonadism
排除标准
- •Uncooperative Subjects
- •Impaired hepatic function indicated by SGOT/SGPT >2.5 times the upper limit of normal.
- •Abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal; elevated creatinine, males > 125 µmol/L or 1.4mg/dl, females > 110 µmol/L or1.2mg/dl)
- •Patients suffering from CAD
- •History of malignancy
- •History of hypersensitivity to any of the investigational drugs
- •Receiving any other testosterone booster therapy/medication/supplement within the last 2 months
- •History of coagulopathies
- •High alcohol intake (>2 standard drinks per day)
- •History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •Any medical condition, where the investigator feels participation in the study could be detrimental to the subjects overall well-being.
结局指标
主要结局
% Change in serum Testosterone levels
时间窗: 12 weeks
次要结局
- % improvement in sperm count(12 weeks)
