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Allopurinol and Quality of Life

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05828836
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to evaluate the impact of allopurinol on patients' related quality of life.

Condition or Disease Intervention/Treatment Phase
  • Drug: Allopurinol Tablet
  • Drug: Placebo
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
the Impact of Allopurinol of HRQOL in Cirrhotic Patients
Actual Study Start Date :
Jun 15, 2022
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
May 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: placebo

Drug: Placebo
placebo once daily
Active Comparator: allopurinol

Drug: Allopurinol Tablet
allopurinol300mg once daily

Outcome Measures

Primary Outcome Measures

  1. CLDQ [6 months]

    effect on CLDQ score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

cirrhosis adult both sex

Exclusion Criteria:
  • renal insufficiency

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Pharmacy Tanta Egypt 31679

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Khadija Ahmed Mhrose Glal, assistant lecturer, Tanta University
ClinicalTrials.gov Identifier:
NCT05828836
Other Study ID Numbers:
  • AqOL
First Posted:
Apr 25, 2023
Last Update Posted:
Apr 25, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Cirrhosis
Allopurinol

Study Results

No Results Posted as of Apr 25, 2023