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
Intervention: Divaza; Placebo
Intervention description: Oral administration.; Oral administration.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of both genders aged 40-75 years old inclusive.

          2. Diagnosis of cerebral atherosclerosis verified by all three signs:

               -  underlying vascular disease (atherosclerosis and/or hypertension) and focal
                  neurological symptoms combined with cerebral symptoms (headache, dizziness,
                  tinnitus, impaired memory, working capacity);

               -  ultrasound signs of atherosclerotic cerebrovascular lesions (according to MAH
                  duplex scanning within 6 months preceding the patient enrollment into the study);

               -  signs of morphological changes in the brain based on neuroimaging (CT/MRI 1.0-1.5
                  T) (subcortical and periventricular leukoaraiosis and/or focal changes in grey
                  matter and white matter in the form of postischemic cysts and/or lacunar strokes
                  and/or diffuse atrophic changes in the form of dilated cardiovascular system or
                  subarachnoidal spaces).

          3. Cognitive disorders (MoCa <26).

          4. Patients with unchanged dose and combination of basic therapy of cerebral
             atherosclerosis and hypertension during the previous month.

          5. Patients who gave their consent to use reliable contraception during the study.

          6. Availability of signed patient information sheet and informed consent form for
             participation in the clinical trial.

        Exclusion Criteria:

          1. History of subarachnoidal/parenchymatous/ventricular hemorrhage, cerebral tumour or
             another disease resulting in neurological disorders.

          2. Ischemic-type stroke or any other acute cerebrovascular accident less than 6 months
             prior to the study with Modified Rankin Scale (mRs) > 1 .

          3. Cardiac sources of high risk or medium risk embolism (TOAST criteria).

          4. Signs of acute or exacerbated chronic infectious diseases at or less than 2 weeks
             prior to screening.

          5. History of CNS diseases including:

               -  Inflammatory CNS diseases (G00-G09)

               -  Systemic Atrophies Primarily Affecting the CNS (G10-G13)

               -  Other degenerative diseases of the nervous system (G30-G32)

               -  Demyelinating diseases of the CNS (G35-G37).

          6. Dementia (F00-F03).

          7. Previously diagnosed cardiovascular diseases with functional class III or IV
             (according to New York Heart Association, 1964).

          8. Hypothyroidism, diabetes mellitus and other somatic diseases at decompensation stage.

          9. Uncontrollable hypertension: SBP > 180 mm Hg and/or DBP > 110 mm Hg.

         10. Diseases of lower limb veins (lower limb varicose veins, deep venous thrombosis, etc.)
             at decompensation stage.

         11. Any other severe concomitant pathology which, according to the investigator, may
             interfere with the patient's participation in the study.

         12. History/suspicion of oncology of any location (except for benign neoplasms).

         13. Allergy/intolerance of any component of the drug products used in the therapy.

         14. Hereditary lactose intolerance.

         15. Malabsorption syndrome, including congenital or acquired lactase deficiency (or any
             other disaccharidase deficiency) and galactosemia.

         16. Pregnancy, breast-feeding.

         17. History of treatment non-compliance, psychiatric disorders, alcoholism or drug abuse
             which, according to the investigator, may interfere with the study procedures.

         18. Use of any medicine indicated in the section "Prohibited concomitant treatment" within
             1 month prior to enrollment.

         19. Participation in other clinical trials in the previous 3 months.

         20. Patients who are related to any of the on-site research personnel directly involved in
             the study or are an immediate relative of the study investigator, or has another
             conflict of interests. 'Immediate relative' means husband, wife, parent, son,
             daughter, brother, or sister (regardless of whether they are natural or adopted).

         21. Patients who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees,
             temporary contract workers, appointed officials responsible for carrying out the
             research or immediate relatives of the aforementioned).