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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 July 2016 |
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Main ID: |
NCT02748005 |
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Date of registration:
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20/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Furosap in Human Volunteers
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Scientific title:
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Asses the Efficacy of Furosap: A Testosterone Booster Supplement in Human Volunteers |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02748005 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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India
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Key inclusion & exclusion criteria
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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
Age minimum:
35 Years
Age maximum:
65 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hypogonadism
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Intervention(s)
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Dietary Supplement: Fenugreek seeds extract 500 mg
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Primary Outcome(s)
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% change in Serum Testosterone level
[Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline]
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% improvement in sperm count
[Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline]
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Secondary ID(s)
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CR/TEST-5-14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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