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Trial · NCT04834557

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

NCT04834557, Phase 2, Completed, Tanta University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis. Trials, record NCT04834557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04834557

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis
NCT number
NCT04834557
Status
Completed
Phases
Phase 2
Enrollment
90 participants, actual
Lead sponsor
Tanta University
Conditions
Rheumatoid Arthritis
Interventions
Placebo, Digoxin 0.25 mg, Ursodeoxycholic acid (UDCA) 500 mg
First posted
2021-04-08
Last updated
2023-03-22

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChanges from Baseline in Clinical Disease Activity Index (CDAI) ScoreBaseline, after 12 weeks, after 24 weeks
To evaluate the effect of the use of digoxin and UDCA as an add-on therapy in patients with rheumatoid arthritis by evaluating the change from baseline in the clinical findings as measured by Clinical Disease Activity Index (CDAI) scores. A lower CDAI score from Baseline would mean improvement in disease activity and an increase in CDAI score from Baseline would mean an increase in disease activity or a worsening in disease activity. Scores: 0.0-2.8 = Range for Remission; 2.9-10.0 = Range for Low disease activity; 10.1-22.0 Range for Moderate disease activity; 22.1-76 Range for High disease activity. Total range is from 0-100, with the high scores representing high disease activity.
PrimaryChanges in C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR)Baseline, after 12 weeks, after 24 weeks
C- reactive Protein (CRP) values and Erythrocyte Sedimentation Rate (ESR) will be made at baseline and after 12 as well as 24 weeks to determine the number of patients whose test result improved or worsened CRP value (normal range \<1.0 mg/dl). ESR (normal range 0-28 mm/hr) . If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved.
SecondaryChanges from baseline Measurement of IL-17A and HIF-1α at 12 and 24 weeksBaseline, after 12 weeks, after 24 weeksSerum IL-17A and HIF-1α levels will be measured by means of the human enzyme-linked immunosorbent assay (ELISA) technique according to the manufacturer's protocol.
SecondaryNumbers of participants with treatment-related adverse eventsBaseline, after 12 weeks, after 24 weeksThe adverse events in each group will be observed and documented during the whole procedure to show the safety of the treatment.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
20872595BACKGROUNDPubMed
20872596BACKGROUNDPubMed
27340129BACKGROUNDPubMed
27445820BACKGROUNDPubMed
28539269BACKGROUNDPubMed
32106058BACKGROUNDPubMed
39498340DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04834557

GET https://conductscience.org/api/trials/v1/NCT04834557/registered