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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
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis, Liver

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 12, 2023
Last Updated
April 12, 2023
Sponsor
Tanta University
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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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