Cytoflavin in the Treatment of Patients With Diabetic Polyneuropathy
Status:
Completed
Trial end date:
2021-06-06
Target enrollment:
Participant gender:
Summary
One of the most common complications of diabetes mellitus is diabetic polyneuropathy, which
leads to disability and reduces quality of life. The toxic effects of high glucose
concentrations contribute to the formation of ketoaldehyde free radicals, which, at an
increased rate of their formation, leads to the development of oxidative stress in the
nervous tissue. The planned study of the use of Cytoflavin® in diabetic polyneuropathy is
substantiated by its antioxidant effect, which, by analogy with alpha-lipoic acid
preparations, suggests its efficacy in the combined treatment of such patients. This clinical
study is being conducted to assess the efficacy and safety of Cytoflavin® versus Placebo in
diabetic polyneuropathy patients with type 2 diabetes. Study patients will receive study
medication, 10 IV infusions followed by 75 days of oral intake. Clinical efficacy will be
assessed by alleviation of symptoms (burning, numbness, pain and pricking), using the total
symptoms score(TSS), after the completion of the treatment course.
Phase:
Phase 3
Details
Lead Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company