Statin Impact on Hepatic Decompensation

NCT ID: NCT05563389

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2023-02-25

Brief Summary

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

Detailed Description

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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

Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PLACEBO

placebo formula

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo arm

statin

atorvastatin tablets

Group Type ACTIVE_COMPARATOR

Atorvastatin 20mg

Intervention Type DRUG

active arm

Interventions

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Atorvastatin 20mg

active arm

Intervention Type DRUG

Placebo

placebo arm

Intervention Type DRUG

Other Intervention Names

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atorvastatin

Eligibility Criteria

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Inclusion Criteria

* cirrhosis adult both sex

Exclusion Criteria

* renal insufficiency
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Khadija Ahmed Mhrose Glal

Assistant lecturer of clinical pharmacy- Clinical pharmacy department- Faculty of pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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khadija glal

Role: PRINCIPAL_INVESTIGATOR

assistant lecturer

Locations

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Tanta University

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Statin and iver cirrhosis

Identifier Type: -

Identifier Source: org_study_id

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