Clinical Trials Logo
  1. Home
  2. Diabetic Neuropathies
  3. NCT04649203

Cytoflavin in the Treatment of Patients With Diabetic Polyneuropathy — CYLINDER  

Diabetic Neuropathies Clinical Trial

Official title:
Multicenter, Double-blind, Placebo-controlled Randomized Clinical Trial of Efficacy and Safety of the Drug Cytoflavin®, Administered Intravenously Followed by Oral Intake, in Patients With Diabetic Polyneuropathy

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04649203
Study type Interventional
Source POLYSAN Scientific & Technological Pharmaceutical Company
Contact
Status Completed
Phase Phase 3
Start date November 25, 2020
Completion date June 6, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05683106 - Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy N/A
Withdrawn NCT04106050 - Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy Phase 1
Completed NCT04088929 - The Use of a Water Soluble Under the Tongue (Sublingual) CBD Tablet for Treating Pain Associated With Diabetic Peripheral Neuropathy Phase 2
Completed NCT01939366 - Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves Phase 2
Withdrawn NCT00815932 - The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To CRPS or Diabetic Neuropathy N/A
Completed NCT01926522 - Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients N/A
Not yet recruiting NCT01180608 - Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain N/A
Completed NCT00760955 - Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy Phase 2
Completed NCT00380913 - Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy Phase 4
Terminated NCT00756041 - Safety Study of TAK-128 in Subjects With Diabetic Peripheral Neuropathy Phase 2
Completed NCT05255497 - The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy N/A
Completed NCT06061237 - Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy N/A
Terminated NCT02915263 - The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes Phase 2
Enrolling by invitation NCT05043636 - Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
Completed NCT06373809 - Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy Early Phase 1
Completed NCT05968131 - Comparative Effects of Proprioceptive Training and Routine Physical Therapy on Diabetic Peripheral Neuropathy N/A
Completed NCT00282685 - Safety and Feasibility Study of Autologous Progenitor Cell Transplantation in Diabetic Neuropathy Phase 1
Completed NCT00135109 - Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy Phase 3
Completed NCT06292962 - Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain N/A
Completed NCT05058807 - Effects of Whole Body Vibration in Diabetic Peripheral Neuropathy . N/A