Clinical Trial of Efficacy and Safety of Divaza for Adjustment of Oxidative Disorders in Patients With Cerebral Atherosclerosis
Condition: Cerebral Atherosclerosis
MeSH terms: Intracranial Arteriosclerosis; Atherosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to obtain additional data on efficacy and safety of Divaza for
      adjustment of oxidative disorders 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 description: 
      Design - a multicenter randomized double-blind placebo-controlled parallel-group clinical
      trial.

      The study will enroll the patients of either gender aged 40-75 years old inclusively with
      verified atherosclerotic cerebrovascular lesions (ICD-10 code - "Cerebral atherosclerosis"
      [I67.2]), with cognitive disorders (МоСА<26), without relevant incapacity (mRs≤1).

      At screening visit (Visit 1, from day - 5 to day 0), after signing patient information sheet
      (informed consent form) for participation in the clinical study the patient's complaints and
      medical history will be collected and objective examination will be carried out. The
      investigator will assess intensity of cognitive disorders using MoCA, extent of functional
      capacity using mRs .

      If the patient meets inclusion criteria and has no exclusion criteria at Visit 2 (Day 0)
      he/she will be randomized to one of two groups: group 1 will receive Divaza at 2 tablets 3
      times a day; group 2 - placebo using study drug scheme.

      Laboratory examination will be performed.

        1. oxidant and antioxidant systems (Fe2+-induced chemoluminescence method, ELISA) defining:
           1.1. level of preformed LP products, predominantly lipid hydroperoxides; 1.2. low and
           very low density lipoprotein resistance to LP; 1.3. lipoprotein potential for oxidation;
           1.4. serum NO product concentration (Griess reaction).

        2. compensatory potential of endothelium and its ability for adequate regulation of
           vascular tone with : 2.1. determination of platelet aggregation with bandage sign; 2.2.
           MAH duplex scanning. Procedures of Visit 2 may be performed on day of Visit 1 if general
           rules for blood collection are met, at that previously performed procedures will not be
           repeated.

      The first administration of Divaza or Placebo will be performed at Visit 2 at medical site in
      the investigator's presence. The patient monitoring and therapy will last for 12 weeks during
      which 3 additional visits will be made.

      At Visit 3 (Week 4±5 days) the investigator will collect the complaints, perform objective
      examination, evaluate intensity of cognitive disorders (MoCA). The investigator will monitor
      the prescribed, basic and concomitant therapy, evaluate therapeutic safety.

      At Visit 4 (Week 8±5 days) the investigator will make a phone call to the patient to evaluate
      safety of the treatment.

      At the final Visit 5 (Weeks 12±5 days) the investigator will evaluate intensity of cognitive
      disorders (MoCA). Laboratory examination of oxidant and antioxidant systems, compensatory
      potential of endothelium and its potential for adequate vascular tone regulation. The
      investigator will monitor the prescribe, basic and concomitant therapy, evaluate therapeutic
      safety and treatment compliance.

      During the study basic, concomitant therapy will be allowed except for the products indicated
      in the section "Prohibited concomitant therapy".
    

Intervention name(s): Divaza; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration.; Oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment