Statin Impact on Hepatic Decompensation

Phase 2

Completed

• Conditions: Quality of Life
• Interventions: Drug: Atorvastatin 20mg; Drug: Placebo

• Registration Number: NCT05563389
• Lead Sponsor: Tanta University

Brief Summary

The study aims to evaluate the impact of statin on hepatic decompensation.

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 Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-03
• Primary Completion: 2023-02-25
• Study Completion: 2023-02-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• cirrhosis adult both sex

Exclusion Criteria

• renal insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
statin	Atorvastatin 20mg	atorvastatin tablets
PLACEBO	Placebo	placebo formula

Primary Outcome Measures

Name	Time	Method
impact on decompensation	6 months	change in recurrence of cirrhosis related complications

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Egypt