Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt
Placebo
+ Ursodeoxycholic acid (UDCA) 500 mg
Arthritis+6
+ Arthritis, Rheumatoid
+ Autoimmune Diseases
Treatment Study
Summary
Study start date: May 1, 2023
Actual date on which the first participant was enrolled.This clinical trial is being conducted to see if a medicine called ursodeoxycholic acid (UDCA) can help reduce inflammation and disease activity in people with rheumatoid arthritis. Rheumatoid arthritis is a condition where the body's immune system attacks its own joints, leading to pain and swelling. The study focuses on patients in Egypt who are already receiving standard treatments for rheumatoid arthritis but still experience varying levels of disease activity. By adding UDCA to their treatment regimen, researchers hope to find an effective way to improve the lives of these patients by potentially reducing joint inflammation and improving overall disease management. In this study, 60 people with rheumatoid arthritis will participate. They will be divided into two groups; one group will receive their usual arthritis medications along with a placebo, while the other group will receive their usual medications plus UDCA at a dose of 500 mg per day. This treatment will continue for 24 weeks. Researchers will conduct medical exams and laboratory tests at the start, then again at 12 weeks and 24 weeks, to assess how well UDCA is working. They will be looking at how UDCA affects inflammation and disease activity in the participants. The study is designed to track the safety and potential benefits of adding UDCA to standard rheumatoid arthritis treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location