Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04649203
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2020-11-24
Brief Title:
Cytoflavin in the Treatment of Patients With Diabetic Polyneuropathy
Sponsor:
POLYSAN Scientific Technological Pharmaceutical Company
Organization:
POLYSAN Scientific Technological Pharmaceutical Company
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CYLINDER
Brief 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 scoreTSS after the completion of the treatment course
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None