Epimedium Prenylflavonoid (EP) Extract for Osteoporosis and Cardiovascular Disease

National University Health System (NUHS)

Status and phase: Unknown; Phase 1

Conditions: Osteoporosis; Cardiovascular Disease

Treatments: Drug: Placebo; Drug: Epimedium Prenylflavonoids Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT02931305

EP2016

Details and patient eligibility

About

The primary objective of the trial is to develop Epimedium Prenylflavonoid (EP) extract as a pharmaceutical-quality intervention for post-menopausal osteoporosis and cardiovascular disease. There will be 3 cohorts of 10 healthy men each for the Phase 1 study. In each cohort, 8 men will receive the Epimedium capsules and 2 men will received the matched controls.

Full description

Prenylflavonoids and its glycoside derivatives isolated from the Traditional Chinese Medicine (TCM), Epimedium, have potent estrogenic properties. The principal bioactive compounds in Epimedium are the prenylflavonoids, icaritin, and their glycosylated derivatives which can enhance osteoblastic differentiation and mineralization, inhibits bone resorption, and induces apoptosis of osteoclasts. Animal experiments indicate that icariin can prevent bone loss induced by ovariectomized (OVX) in rats, through its stimulatory effects on osteoblast growth and function, and inhibitory action on osteoclast cells.

Epimedium has also demonstrated significant cardiovascular benefits with positive actions on vascular reactivity, endothelial function and thrombosis in human subjects. Notably, icariin, demonstrated a significant nitric oxide (NO)-dependent vasorelaxation of precontracted coronary arterial rings with intact endothelium in a concentration-dependent manner, via the activation of endothelial nitric oxide synthase protein and NO-cyclic guanidine monophosphate (cGMP) pathway. Epimedium prenylflavonoids (EP) can prevent steroid-associated osteonecrosis in rabbit model and notably, reduce thrombosis incidence and shrink fat-cell-size significantly. This striking combination of properties highlights the immense potential in EP for osteoporosis and cardiovascular health.

Enrollment: 30 estimated patients

Sex: Male

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men.

Exclusion criteria

• Hepatitis B patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Epimedium Prenylflavonoids Extract

Experimental group

Description:

Single oral doses of EP (370 mg, 740 mg and 1110 mg) capsules would be orally administered.

Treatment:

Drug: Epimedium Prenylflavonoids Extract

Placebo

Placebo Comparator group

Description:

Single oral doses of Placebo (370 mg, 740 mg and 1110 mg) capsules would be orally administered.

Treatment:

Drug: Placebo