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Statin Impact on Quality of Life in Cirrhotic Patients

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05563389
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
14.5
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to evaluate the impact o0f statin on parents' related quality of life.

Condition or Disease Intervention/Treatment Phase
  • Drug: Atorvastatin 20mg
  • 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 Statin on Quality of Life in Cirrhotic Patients
Anticipated Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Sep 25, 2023
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: PLACEBO

Drug: Placebo
placebo arm
Active Comparator: statin

Drug: Atorvastatin 20mg
active arm

Outcome Measures

Primary Outcome Measures

  1. impact on patient related quality of life [6 months]

    change in chronic liver disease questionnare

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 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 Tanta University Tanta Egypt

Sponsors and Collaborators

  • Tanta University

Investigators

  • Principal Investigator: khadija glal, assistant lecturer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Khadija Ahmed Mhrose Glal, Assistant lecturer of clinical pharmacy- Clinical pharmacy department- Faculty of pharmacy, Tanta University
ClinicalTrials.gov Identifier:
NCT05563389
Other Study ID Numbers:
  • Liver cirrhosis
First Posted:
Oct 3, 2022
Last Update Posted:
Nov 7, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atorvastatin

Study Results

No Results Posted as of Nov 7, 2022