NCT02748005

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
Last Updated

June 30, 2016

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

April 20, 2016

Last Update Submit

June 29, 2016

Conditions

Hypogonadism

Keywords

Fenugreek seed extracttestosteroneprotodioscinhypogonadism

Outcome Measures

Primary Outcomes (2)

  • % change in Serum Testosterone level

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

  • % improvement in sperm count

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

Study Arms (1)

Fenugreek seeds extract 500 mg

EXPERIMENTAL

Fenugreek seeds extract(Furosap) 500 mg

Dietary Supplement: Fenugreek seeds extract 500 mg

Interventions

Fenugreek seeds extract 500 mgDIETARY_SUPPLEMENT

one cap once a day

Also known as: Furosap
Fenugreek seeds extract 500 mg

Eligibility Criteria

Age35 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saroj Hospital & Maternity Centre

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

Location

Related Publications (4)

  • 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.

    PMID: 21312304BACKGROUND

  • 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.

    PMID: 20878698BACKGROUND

  • 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.

    PMID: 20507258BACKGROUND

  • 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.

    PMID: 12804079BACKGROUND

MeSH Terms

Conditions

Hypogonadism

Interventions

Furosap

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 22, 2016

Study Start

August 1, 2014

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

June 30, 2016

Record last verified: 2015-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)