Viewing Study NCT06656169



Ignite Creation Date: 2024-10-26 @ 3:43 PM
Last Modification Date: 2024-10-26 @ 3:43 PM
Study NCT ID: NCT06656169
Status: RECRUITING
Last Update Posted: None
First Post: 2024-10-03

Brief Title: Effect of Subcutaneous Polyvidone Collagen Treatment on Hand Recovery in Adult Rheumatoid Arthritis
Sponsor: None
Organization: None

Study Overview

Official Title: Effect of Subcutaneous Polyvidone Collagen Treatment vs Placebo on Clinical Hand Recovery Biochemical Response and Quality of Life in Adult Rheumatoid Arthritis
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: A study in geriatric rheumatology on the treatment of rheumatoid arthritis RA in older adults is described Its objective is to compare the effects of subcutaneous polyvidone collagen versus placebo analyzing clinical improvement biochemical response and quality of life in people over 60 years of age

The Phase IV double-blind randomized placebo-controlled clinical trial will be conducted between 2023 and 2026 Sixty patients with early-stage arthritis will participate assessing factors such as pain functionality and synovitis with various statistical tools and analyses
Detailed Description: Geriatric rheumatology specializes in the study of rheumatic diseases in older adults who have immune and physiological characteristics that influence the manifestation of these diseases In the case of rheumatoid arthritis RA a chronic inflammatory disease that affects the joints treatments that improve functionality and reduce pain in the hands evaluated by ultrasound are studied

Its objective is to compare the effects of treatment with subcutaneous polyvidone collagen versus placebo on clinical improvement of the hands biochemical response and quality of life in people over 60 years of age with rheumatoid arthritis

A Phase IV double-blind randomized placebo-controlled clinical trial will be conducted between August 2023 and August 2026 Sixty patients 30 in each group with early-stage arthritis will participate Pain functionality synovitis and quality of life will be assessed using various scales biochemical analyses and statistical tests

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None