Last updated: March 21, 2023
Sponsor: Tanta University
Overall Status: Completed
Phase
2
Condition
Arthritis And Arthritic Pain
Rheumatoid Arthritis
Joint Injuries
Treatment
N/AClinical Study ID
NCT04834557
Treating Rheumatoid Arthritis
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosed with rheumatoid arthritis according to the ACR/EULAR 2010 criteria.
- Having active rheumatoid arthritis disease activity (the 28-joint disease activityscore [DAS28] according to the CRP formula > 2.6).
- Aged between 18 and 80 years.
- With clear consciousness and able to cooperate with this study.
- Personal willingness and ability to comply with the study follow-up schedule and otherrequirements of the study protocol.
- Both male and female will be included
- All patients receiving non-biological drugs will be also included.
- Sign an informed consent for the clinical study.
Exclusion
Exclusion Criteria:
- Pregnant or planning to be pregnant and breast-feeding women
- Patients suffering from any chronic diseases
- Patients with other autoimmune diseases, such as systemic lupus erythematosus,Sjogren's syndrome and mixed connective tissue disease.
- Patients who have a diagnosis of any other inflammatory arthritis (e.g., psoriaticarthritis or ankylosing spondylitis).
- Patients with a history of, or suspected, demyelinating disease of the central nervoussystem (e.g. multiple sclerosis or optic neuritis).
- Patients with a current or recent history of severe, progressive, and/or uncontrolledrenal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac,neurological, or cerebral disease.
- Patients treated with biological therapy such as TNF-α or IL-1β antagonists.
- Patients with infectious or inflammatory diseases, endocrine disorders, any past orcurrent psychiatric or neurological diseases.
- Patients with cardiovascular diseases such as arrhythmias and acute myocardialinfarction.
- Patients with electrolyte disturbances (such as hypokalemia, hypomagnesemia, andhypercalcemia) could potentially elevate the risk of digoxin toxicity.
- Patients with clinically significant hepatic and renal dysfunction or impairment.
- Alcohol abuse
- Patients with evidence of viral (HBV or HCV), autoimmune hepatitis, and decompensatedliver disease.
- Patients with cancer currently diagnosed or in medical history, if no recovery wasachieved.
- Patients who are allergic to digoxin or Ursodeoxycholic acid (UDCA)
- Patients who are unconscious and unable to complete the study.
- Patients with acute inflammation of the gall bladder or the biliary tract, frequentepisodes of biliary colic, and impaired contractility of the gall bladder, will beexcluded.
- Patients with cholestasis, primary biliary cirrhosis, or biliary obstruction will alsobe excluded.
- Patients who have received an organ transplant.
Study Design
Total Participants: 90
Study Start date:
November 01, 2021
Estimated Completion Date:
September 30, 2022
Study Description
Connect with a study center
Menoufia University Hospital
Shibīn Al Kawm,
EgyptSite Not Available

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