An interventional study of silymarin and Ursodeoxycholic Acid in Fibrosis, Liver, sponsored by Zagazig University. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-11-27.
Sponsored by Zagazig University · Not applicable, Interventional, and Treatment
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 400 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: silymarin · Drug: Ursodeoxycholic Acid · Drug: Antioxidants · Drug: Colchicine · Other: FOLLOW UP
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
Other: FOLLOW UP
silymarin 140 three times daily
Also known as: silymarin 140
Ursodeoxycholic Acid 500
Also known as: ursofalk
Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg
Also known as: antox
Colchicine 0.6
follow up by abdominal ultrasound and fibroscan every 6 month for 1 year
Also known as: ultrasound and fibroscan
Improvement in liver stiffness measurement by Fibroscan
Liver stiffness assessment by Fibroscan every 6 months
Time frame: 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
Time frame: 1 year
Improved splenic stiffness measurement
assessment by ultrasound and fibroscan
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Zagazig University