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Cytoflavin in the Treatment of Patients With Diabetic Polyneuropathy

NCT04649203 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2023-01-27

No results posted yet for this study

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.

Conditions

  • Diabetic Neuropathies

Interventions

DRUG

Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)

The study drug will be administered in two phases: intravenous infusion of study drug for 10 days followed by oral administration of study drug for 75 days. Thus, the total duration of the study therapy is 12 weeks.

DRUG

Placebo

The placebo comparator will be administered in two phases: intravenous infusion of placebo solution for 10 days followed by oral administration of placebo pills for 75 days. Thus, the total duration of the study therapy is 12 weeks.

Sponsors & Collaborators

  • POLYSAN Scientific & Technological Pharmaceutical Company

    lead INDUSTRY

Principal Investigators

  • Igor A Strokov, Prof. · "First Moscow State Medical University n.a. I.M.Sechenov of the Ministry of Health of Russia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2021-03-29
Completion
2021-06-06

Countries

  • Russia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04649203 on ClinicalTrials.gov