The Efficacy Study of FUROSAP: A Testosterone Booster Supplement In Humans.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02702882|
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : September 15, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism||Dietary Supplement: Fenugreek Seeds Extract||Not Applicable|
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.
Protodioscin is the active ingredient found in the extract of the plant. Protodioscin increases levels of the hormones testosterone, dihydrotestosterone and dehydroepiandrosterone. It boosts testosterone level via stimulating pituitary gland. Protodioscin acts by stimulating the enzyme 5- alpha-reductase, which plays a role in the conversion of testosterone into dihydrotestosterone. Dihydrotestosterone, in turn enhances erythropoiesis and muscle development. More erythropoiesis or production of red blood cell increases the haemoglobin level, which results in better oxygen transport throughout the body, resulting in a more optimal health. Both increased production of testosterone contribute to the increase in sexual functions, and it increases unbound free testosterone levels, which improves muscle mass, fat loss, strength and endurance. In addition, protodioscin also stimulates the hypothalamus secretion of luteinizing hormone (LH) which also helps to increase the level of testosterone.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open level|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficacy Evaluation of Furosap, a Testosterone Booster Supplement in Human Volunteers : An add-on Study|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Fenugreek seeds extract 500 mg
Fenugreek seeds extract ( Furosap) one caps once a day
Dietary Supplement: Fenugreek Seeds Extract
Furosap one caps OD
Other Name: Furosap
- % Change in serum Testosterone levels [ Time Frame: 12 weeks ]
- % improvement in sperm count [ Time Frame: 12 weeks ]
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|Ages Eligible for Study:||35 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702882
|Department of Urology, King George's Medical University, Lucknow, UP, India|
|Lucknow, Uttar Pradesh, India, 226003|
|Principal Investigator:||Dr. Satyanarayan sankhwar, M.S., M.Ch.||King George's Medical University, Lucknow, UP, India|
|Responsible Party:||Chemical Resources|
|Other Study ID Numbers:||
|First Posted:||March 9, 2016 Key Record Dates|
|Last Update Posted:||September 15, 2017|
|Last Verified:||May 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Fenugreek seed extract, hypogonadism, protodioscin, testosterone
Endocrine System Diseases
Fenugreek seed meal
Physiological Effects of Drugs