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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Active Comparator | 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 |
|
| control group | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silymarin | Drug | silymarin 140 three times daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in liver stiffness measurement by Fibroscan | Liver stiffness assessment by Fibroscan every 6 months | 1 year |
| Improved portal hypertension parameters | Assessment of portal vein diameter, splenic vein diameter, portal vein congestive index by ultrasound and Doppler every 6 months | 1 year |
| Improved splenic stiffness measurement | assessment by ultrasound and fibroscan | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012838 | Silymarin |
| D014580 | Ursodeoxycholic Acid |
| D000975 | Antioxidants |
| D003078 | Colchicine |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D044947 | Flavonolignans |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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200 patients will receive silymarin 420 mg + antioxidants + colchicine
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| Ursodeoxycholic Acid | Drug | Ursodeoxycholic Acid 500 |
|
|
| Antioxidants | Drug | Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg |
|
|
| Colchicine | Drug | Colchicine 0.6 |
|
| FOLLOW UP | Other | follow up by abdominal ultrasound and fibroscan every 6 month for 1 year |
|
|
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
| D001685 | Biological Factors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020011 | Protective Agents |
| D045505 | Physiological Effects of Drugs |
| D020313 | Specialty Uses of Chemicals |
| D000470 | Alkaloids |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |