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Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis

NCT04834557 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-03-22

No results posted yet for this study

Summary

The purpose of this study is to investigate the potential therapeutic effects of the cardiac glycoside digoxin and the secondary bile acid ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity when administered as add-on treatments to the current DMARDs treatments for rheumatoid arthritis patients with variant disease activity.

Conditions

Interventions

DRUG

Placebo

Placebo will be administered to the control group for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.

DRUG

Digoxin 0.25 mg

All subjects will receive digoxin administered at 0.25 mg every other day for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.

DRUG

Ursodeoxycholic acid (UDCA) 500 mg

All subjects will receive Ursodeoxycholic acid (UDCA) administered at 500 mg/day for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Principal Investigators

  • Nageh Ahmed El-Mahdy, Professor · Professor of Pharmacology and Toxicology Faculty of Pharmacy, Tanta University

  • Medhat Ismail Abdel Hamid, Professor · Professor of Pharmacology and Toxicology Faculty of Medicine, Al-Azhar University

  • Dalia Salah Seif, PHD · Associate Professor of Physical Medicine, Rheumatology and Rehabilitation Faculty of Medicine, Menoufyia University

  • Enass Yousef Osman, PHD · Lecturer of Pharmacology and toxicology, Faculty of Pharmacy, Tanta University

  • Mariam George Tadros Bolous, Master · Assistant Lecturer of Clinical pharmacy, Faculty of Pharmacy, Sinai University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-05-18
Completion
2022-09-30

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04834557 on ClinicalTrials.gov