- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02748005
Evaluation of Furosap in Human Volunteers
Asses the Efficacy of Furosap: A Testosterone Booster Supplement in Human Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
U P
-
Kanpur Hardoi Ring Road, Para,Lucknow, U P, India, 226017
- Saroj Hospital & Maternity Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fenugreek seeds extract 500 mg
Fenugreek seeds extract(Furosap) 500 mg
|
one cap once a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
% change in Serum Testosterone level
Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline
|
On completion of treatment (i.e.12 weeks) as compared to baseline
|
% improvement in sperm count
Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline
|
On completion of treatment (i.e.12 weeks) as compared to baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Steels E, Rao A, Vitetta L. Physiological aspects of male libido enhanced by standardized Trigonella foenum-graecum extract and mineral formulation. Phytother Res. 2011 Sep;25(9):1294-300. doi: 10.1002/ptr.3360. Epub 2011 Feb 10.
- Aswar U, Bodhankar SL, Mohan V, Thakurdesai PA. Effect of furostanol glycosides from Trigonella foenum-graecum on the reproductive system of male albino rats. Phytother Res. 2010 Oct;24(10):1482-8. doi: 10.1002/ptr.3129.
- Hamden K, Jaouadi B, Carreau S, Aouidet A, El-Fazaa S, Gharbi N, Elfeki A. Potential protective effect on key steroidogenesis and metabolic enzymes and sperm abnormalities by fenugreek steroids in testis and epididymis of surviving diabetic rats. Arch Physiol Biochem. 2010 Jul;116(3):146-55. doi: 10.3109/13813455.2010.486405.
- Gauthaman K, Ganesan AP, Prasad RN. Sexual effects of puncturevine (Tribulus terrestris) extract (protodioscin): an evaluation using a rat model. J Altern Complement Med. 2003 Apr;9(2):257-65. doi: 10.1089/10755530360623374.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR/TEST-5-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypogonadism
-
Rigshospitalet, DenmarkTerminatedHypogonadotropic Hypogonadism | Hypogonadism | Hypogonadism, MaleDenmark
-
Shanghai Jiao Tong University School of MedicineUnknownIdiopathic Hypogonadotropic Hypogonadism
-
Endo PharmaceuticalsCompletedHypogonadotropic Hypogonadism | Hypogonadism | Hypogonadism, MaleUnited States
-
Clarus Therapeutics, Inc.CompletedMale Hypogonadism | Secondary Hypogonadism | Primary HypogonadismUnited States
-
Amneal Pharmaceuticals, LLCPhase One Solutions, Inc.CompletedHypogonadotropic Hypogonadism | Primary HypogonadismUnited States
-
Endo PharmaceuticalsCompletedHypogonadism | Secondary Hypogonadism | Primary HypogonadismUnited States
-
Repros Therapeutics Inc.CompletedObesity | Acquired Hypogonadotropic HypogonadismUnited States
-
Massachusetts General HospitalRecruiting
-
Mereo BioPharmaCompleted
-
Organon and CoCompleted
Clinical Trials on Fenugreek seeds extract 500 mg
-
Chemical ResourcesCompletedPoly Cystic Ovary Syndrome
-
Chemical ResourcesCompleted
-
Chemical ResourcesCompleted
-
Jacksonville UniversitySPECNOVA LLCCompletedAging | Testosterone DeficiencyUnited States
-
University of Mary Hardin-BaylorIndus Biotech Ltd. Pvt.CompletedInflammation | Muscle DamageUnited States
-
University of Management and Technology LahoreCompletedGlucose Metabolism Disorders (Including Diabetes Mellitus)Pakistan
-
All India Institute of Medical Sciences, BhubaneswarChemical ResourcesCompletedType-2 Diabetes MellitusIndia
-
Jacksonville UniversitySpecnova, incUnknownMuscle SorenessUnited States
-
Korea Ginseng CorporationNutrasource Pharmaceutical and Nutraceutical Services, Inc.RecruitingCardiovascular Diseases | Platelet Aggregation | Vasodilation | Blood Pressure DisordersUnited States
-
Taipei Hospital, TaiwanNational Science Council, TaiwanCompleted