Last updated on May 2019

Clinical Trial of Efficacy and Safety of Divaza in the Management of Oxidative Disturbances in Cerebral Atherosclerosis

Brief description of study

The purpose of this study is to obtain further data on the efficacy and safety of Divaza therapy for oxidative impairment elimination in patients with cerebral atherosclerosis.

It is assumed that the inclusion of the drug Divaza in the basic therapy will help reduce the severity of cognitive disorders, other clinical symptoms of cerebral atherosclerosis, reduce the impact of the disease on the quality of life of the patient.

Participate in the study may be patients with a diagnosis of "cerebral atherosclerosis", which, against the backdrop of basic therapy with constant doses of drugs (within the last 4 weeks), to achieve a stable course of cerebral atherosclerosis, cognitive disorders without significant disability are detected.

Detailed Study Description

The diagnosis of "cerebral atherosclerosis" is established in the presence of all three causes: a) the main vascular disease and focal neurological symptoms in combination with cerebral symptoms; b) ultrasound signs of atherosclerotic lesion of the cerebrovascular bed (according to data of duplex scanning of the main arteries of the head (MAG)) made in the previous 6 months before the patient was included in the study); c) signs of morphological changes in the brain substance from the data of neuroimaging.

At cerebral atherosclerosis against the background of progressive oxidant disorders, the change in the mean value of resistance of lipoproteins (LP) to lipid peroxygenation (LPO) will be evaluated by the method of Fe2 + -induced chemiluminescence, high specificity and informativity of which was shown in the study of oxidative and antioxidant systems of patients with initial manifestations of chronic cerebrovascular insufficiency.

The average value of resistance of LP to LPO will be determined in the laboratory initially and after 12 weeks of treatment.

Cognitive disorders are significant clinical manifestations of chronic cerebrovascular disease with oxidative disorders, which significantly reduces the quality of life of patients. Changes in cognitive function will be assessed initially and after 12 weeks of treatment by the Montreal Cognitive Assessment (MoCA).

As additional parameters, changes in the mean values of the levels of pre-formulated products of LPO, the ability of LP to oxidation, NO in serum, platelet aggregation and Carotid Intima-Media Thickness (CIMT) at 12 weeks of therapy as compared to the baseline condition.

Clinical Study Identifier: NCT03485495

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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