- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05828836
Allopurinol and Quality of Life in Liver Cirrhosis
October 29, 2023 updated by: Khadija Ahmed Mhrose Glal, Tanta University
the Impact of Allopurinol of HRQOL in Cirrhotic Patients
The study aims to evaluate the impact of allopurinol on patients' related quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cirrhosis is the late stage of liver damage and possess two phases:.
The shift from compensated to decompensated cirrhosis is characterized by the onset of complications) which are associated with substantial morbidity and negative Impact on quality of life (QOL)Cirrhosis and its complications have a substantial economic, social, and personal impact on affected patients, as well as their families and caregivers
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tanta, Egypt, 31679
- Faculty of pharmacy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
cirrhosis adult both sex
Exclusion Criteria:
- renal insufficiency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo
|
placebo once daily
|
|
Active Comparator: allopurinol
|
allopurinol300mg once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chronic liver disease questionnaire
Time Frame: 6 months
|
effect on Chronic liver disease questionnaire score
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2022
Primary Completion (Actual)
January 15, 2023
Study Completion (Actual)
March 1, 2023
Study Registration Dates
First Submitted
April 12, 2023
First Submitted That Met QC Criteria
April 12, 2023
First Posted (Actual)
April 25, 2023
Study Record Updates
Last Update Posted (Actual)
October 31, 2023
Last Update Submitted That Met QC Criteria
October 29, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Liver Diseases
- Fibrosis
- Liver Cirrhosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites
- Protective Agents
- Antioxidants
- Free Radical Scavengers
- Gout Suppressants
- Allopurinol
Other Study ID Numbers
- AqOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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