Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR

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

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-02

Study Completion Date

2018-08-01

Brief Summary

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with the introduction of Direct-acting antiviral agents in the management of HCV, the scope of inclusion criteria had been widened to include patients with compensated cirrhosis and even in special situations patients with decompensated liver disease; a chance that was not offered by the limited and strict inclusion criteria needed for treatment by pegylated interferon-based regimen. this made the number of patients with progressive liver fibrosis of cirrhosis had been inv=creased even after achieving SVR. the debate about the impact of SVR on halting fibrosis progression had risen; some studies postulated that patients benefit from an SVR through reduction of mortality, morbidity, and improved quality of life ; however, some patients may maintain their level of fibrosis or even progress to cirrhosis despite achieving SVR and the risk for HCC remains even after virologic eradication.

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Detailed Description

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Conditions

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Fibrosis, Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

200 patients will receive silymarin 420 mg + antioxidants + colchicine

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group

200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be treated by anti-fibrotic agents

Group Type ACTIVE_COMPARATOR

silymarin

Intervention Type DRUG

silymarin 140 three times daily

Ursodeoxycholic Acid

Intervention Type DRUG

Ursodeoxycholic Acid 500

Antioxidants

Intervention Type DRUG

Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg

Colchicine

Intervention Type DRUG

Colchicine 0.6

FOLLOW UP

Intervention Type OTHER

follow up by abdominal ultrasound and fibroscan every 6 month for 1 year

control group

200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be followed up without any intervention

Group Type PLACEBO_COMPARATOR

FOLLOW UP

Intervention Type OTHER

follow up by abdominal ultrasound and fibroscan every 6 month for 1 year

Interventions

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silymarin

silymarin 140 three times daily

Intervention Type DRUG

Ursodeoxycholic Acid

Ursodeoxycholic Acid 500

Intervention Type DRUG

Antioxidants

Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg

Intervention Type DRUG

Colchicine

Colchicine 0.6

Intervention Type DRUG

FOLLOW UP

follow up by abdominal ultrasound and fibroscan every 6 month for 1 year

Intervention Type OTHER

Other Intervention Names

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silymarin 140 ursofalk antox ultrasound and fibroscan

Eligibility Criteria

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Inclusion Criteria

* chronic HCV
* compensated liver disease (Child class A-B)
* sustained virological response
* liver stiffness by fibroscan \>12.5 kPa denotes cirrhosis

Exclusion Criteria

* decompensated liver disease
* chronic active HCV
* hepatocellular carcinoma
* other liver diseases as alcoholic liver disease, autoimmune liver disease, drug-induced liver disease
* pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No