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HypogonadismNCT02748005

Evaluation of Furosap in Human Volunteers

A study testing Fenugreek seeds extract 500 mg in people with Hypogonadism, run by Chemical Resources at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 35 to 65 years, men only
Conditions the study is for
Hypogonadism
What is being tested?
Fenugreek seeds extract 500 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIndia
Study dates
Aug 2014to Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

India1 site
  • Saroj Hospital & Maternity Centre

    Kanpur Hardoi Ring Road, Para,Lucknow, U P, 226017

Other trials in India

About this study

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

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.

Read the 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.

Conditions
Hypogonadism
Being tested
Fenugreek seeds extract 500 mg
Keywords
Fenugreek seed extract, testosterone, protodioscin, hypogonadism
Medical subject headings
Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fenugreek seeds extract 500 mgDietary supplement

    Also called Furosap

    one cap once a day

Study groups in NCT02748005
Study groupRoleWhat they receive
Fenugreek seeds extract 500 mgExperimentalFenugreek seeds extract(Furosap) 500 mg
Receives: Dietary Supplement: Fenugreek seeds extract 500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. % change in Serum Testosterone level

    Measured: On completion of treatment (i.e.12 weeks) as compared to baseline

  2. % improvement in sperm count

    Measured: On completion of treatment (i.e.12 weeks) as compared to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2016 (estimated)
  2. Study startAug 2014
  3. Primary completionJul 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02748005
Sponsor's protocol ID
CR/TEST-5-14
Status last verified
Aug 2015
First submitted
20 Apr 2016
Last updated
30 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 21312304
  • 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.

    PubMed 20878698
  • 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.

    PubMed 20507258
  • 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.

    PubMed 12804079

Questions about this trial

What is this clinical trial studying?

A study testing Fenugreek seeds extract 500 mg in people with Hypogonadism, run by Chemical Resources at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% change in Serum Testosterone level (time frame: On completion of treatment (i.e.12 weeks) as compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02748005, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.

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