Evaluation of Furosap in Human Volunteers

Hypogonadism Clinical Trial

Official title:

Asses the Efficacy of Furosap: A Testosterone Booster Supplement in Human Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748005
• Other study ID #: CR/TEST-5-14
• Status: Completed
• Phase: N/A
• First received: April 20, 2016
• Last updated: June 29, 2016
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2015
• Source: Chemical Resources
• Contact: n/a
• Is FDA regulated: No
• Health authority: India:Food Safety And Standards Authority of India
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Agrees to written as well as audio-visual informed consent.

2. Ability to understand the risks/benefits of the protocol

3. Male between 35-65 years of age.

4. Diagnosed with Symptomatic hypogonadism

Exclusion Criteria:

1. Uncooperative Subjects

2. Impaired hepatic function indicated by SGOT/SGPT >2.5 times the upper limit of normal.

3. Abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal

4. elevated creatinine, males > 125 µmol/L or 1.4mg/dl, females > 110 µmol/L or1.2mg/dl)

5. Patients suffering from CAD

6. History of malignancy

7. History of hypersensitivity to any of the investigational drugs Receiving any other testosterone booster therapy/medication/supplement within the last 2 months

8. History of coagulopathies

9. High alcohol intake (>2 standard drinks per day)

10. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.

11. Any medical condition, where the investigator feels participation in the study could be detrimental to the subjects overall well-being

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Dietary Supplement:
• Fenugreek seeds extract 500 mg
one cap once a day

Locations

Country	Name	City	State
India	Saroj Hospital & Maternity Centre	Kanpur Hardoi Ring Road, Para,Lucknow	U P

Sponsors (1)

Lead Sponsor	Collaborator
Chemical Resources

Country where clinical trial is conducted

India, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% change in Serum Testosterone level		On completion of treatment (i.e.12 weeks) as compared to baseline	No
Primary	% improvement in sperm count		On completion of treatment (i.e.12 weeks) as compared to baseline	No