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An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement in Senior Men

I

Innovus Pharmaceuticals

Status

Unknown

Conditions

Healthy Aging

Study type

Observational

Funder types

Industry

Identifiers

NCT04584918
INNV-BHT1000-001

Details and patient eligibility

About

To evaluate the effect and support the tolerance of orally ingested formulation containing Eurycoma longifolia dietary supplement (Euryco-10) on a cohort of senior men.

Full description

This is a single-center, single arm, open label study in senior men. This study will investigate the effect and tolerance of oral ingestion of Euryco-10. Subjects meeting all inclusion and none of the exclusion criteria will be enrolled and provided with study dietary supplement. Subjects will be instructed to take 2 capsules per day for 35 days. Administration and any adverse events will be recorded in the subject diary. At each clinic visit (Day 0, Day 21 and Day 35) the Subject will complete the AMS Questionnaire.

Enrollment

12 estimated patients

Sex

Male

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male ≥ 55 years of age

Exclusion criteria

Severe lower urinary tract symptoms.

Current use of any herbal and/or nutritional supplements that can interfere with testosterone.

A history of cancer except melanoma skin cancer.

Currently receiving treatment with cancer chemotherapy or antiandrogens.

Chronic use of systemic glucocorticoids (use within >14 days up to the 3months prior to screening); use of non-testosterone anabolic steroids within12 months prior to screening.

History of frequent opioid use >1 time/week during any week within 30 days prior to screening.

Have a history of known angina.

Have a history of severe liver disease or clinical evidence of hepatic impairment at screening.

Untreated severe obstructive sleep apnea.

Allergies to any of the ingredients in Euryco-10® or BioPerine.

Any condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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