The present study is designed to evaluate the modulatory effect of IP on the vascular endothelial function. To assess its vasodilatation potential, change in flow mediated dilation (FMD) and blood flow velocity (BFV) will be assessed in healthy adult male population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
60
One capsule to be taken stat
One capsule to be taken stat
Vedic Lifesciences
Mumbai, Maharashtra, India
RECRUITINGPercent flow mediated dilatation
To determine change in the endothelial function after single dose administration of Moringa oleifera as assessed by the change in the Percent flow mediated dilatation of brachial artery, from baseline (pre-IP administration) to 3 hours post IP administration, in comparison to the placebo.
Time frame: From baseline (pre-IP administration) to 3 hours post-IP administration
Blood flow velocity
The endothelial function can be assessed by measuring changes in blood flow by intravascular ultrasound. It has been demonstrated that biophysical forces such as flow-derived forces, modulates the vascular structure and function. Endothelium is mechanotransducer, which senses mechanical forces on its surface and the transduces these signals into biochemical signals. There exists a large body of literature regarding the wide spectra of biological signals induced by blood flow in the endothelium.18 Thus to evaluate the effect of Moringa oleifera on hemodynamics, change in blood flow velocity (cm/seconds) will be assessed at baseline (pre-IP administration) and at 1, 2, and 3 hours post-IP administration will be measured.
Time frame: at baseline (pre-IP administration) and at 1, 2, and 3 hours post-IP administration
Percent flow mediated dilatation
To identify the onset of effect of the investigational product, the flow mediated dilation at 1, and 2 hours post-IP administration from baseline (pre-IP administration) will be assessed as a secondary outcome.
Time frame: at 1, and 2 hours post-IP administration from baseline (pre-IP administration)
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