Allopurinol and Quality of Life
Primary Purpose
Cirrhosis, Liver
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Allopurinol Tablet
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis, Liver
Eligibility Criteria
Inclusion Criteria: cirrhosis adult both sex Exclusion Criteria: renal insufficiency
Sites / Locations
- Faculty of PharmacyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
allopurinol
Arm Description
Outcomes
Primary Outcome Measures
CLDQ
effect on CLDQ score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05828836
Brief Title
Allopurinol and Quality of Life
Official Title
the Impact of Allopurinol of HRQOL in Cirrhotic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aims to evaluate the impact of allopurinol on patients' related quality of life.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
allopurinol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Allopurinol Tablet
Intervention Description
allopurinol300mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo once daily
Primary Outcome Measure Information:
Title
CLDQ
Description
effect on CLDQ score
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cirrhosis adult both sex
Exclusion Criteria:
renal insufficiency
Facility Information:
Facility Name
Faculty of Pharmacy
City
Tanta
ZIP/Postal Code
31679
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
khadija glal, master
Phone
01118969649
Email
khadija.ahmed@pharm.tanta.edu.eg
12. IPD Sharing Statement
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Allopurinol and Quality of Life
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