The Efficacy Study of FUROSAP: A Testosterone Booster Supplement In Humans.
Primary Purpose
Hypogonadism
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Fenugreek Seeds Extract
Sponsored by
About this trial
This is an interventional supportive care trial for Hypogonadism focused on measuring Fenugreek seed extract, hypogonadism, protodioscin, testosterone
Eligibility Criteria
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.
Sites / Locations
- Department of Urology, King George's Medical University, Lucknow, UP, India
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Fenugreek seeds extract 500 mg
Arm Description
Fenugreek seeds extract ( Furosap) one caps once a day
Outcomes
Primary Outcome Measures
% Change in serum Testosterone levels
Secondary Outcome Measures
% improvement in sperm count
Full Information
NCT ID
NCT02702882
First Posted
September 29, 2015
Last Updated
September 14, 2017
Sponsor
Chemical Resources
1. Study Identification
Unique Protocol Identification Number
NCT02702882
Brief Title
The Efficacy Study of FUROSAP: A Testosterone Booster Supplement In Humans.
Official Title
Efficacy Evaluation of Furosap, a Testosterone Booster Supplement in Human Volunteers : An add-on Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chemical Resources
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
Fenugreek seed extract, hypogonadism, protodioscin, testosterone
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open level
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fenugreek seeds extract 500 mg
Arm Type
Other
Arm Description
Fenugreek seeds extract ( Furosap) one caps once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Fenugreek Seeds Extract
Other Intervention Name(s)
Furosap
Intervention Description
Furosap one caps OD
Primary Outcome Measure Information:
Title
% Change in serum Testosterone levels
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
% improvement in sperm count
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Satyanarayan sankhwar, M.S., M.Ch.
Organizational Affiliation
King George's Medical University, Lucknow, UP, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, King George's Medical University, Lucknow, UP, India
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21312304
Citation
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.
Results Reference
background
PubMed Identifier
20878698
Citation
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.
Results Reference
background
PubMed Identifier
20507258
Citation
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.
Results Reference
background
PubMed Identifier
12804079
Citation
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.
Results Reference
background
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The Efficacy Study of FUROSAP: A Testosterone Booster Supplement In Humans.
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