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临床试验/NCT02702882
NCT02702882已完成不适用

Efficacy Evaluation of Furosap, a Testosterone Booster Supplement in Human Volunteers : An add-on Study

Chemical Resources2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年2月1日最近更新:
适应症

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

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)

研究者

发起方
Chemical Resources
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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