A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis

Inclusion Criteria:

- Diagnosis of primary sclerosing cholangitis (PSC) established by all of the following
criteria:

- Alkaline phosphatase >1.5x upper limit of normal for at least 6 months prior to
study enrollment

- Cholangiography demonstrating intrahepatic and/or extrahepatic biliary dilation,
beading, and/or strictures consistent with PSC

- Liver histology (if available for review) consistent with or diagnostic of PSC

- Women of child-bearing potential willing to use birth control for the duration of the
study.

Exclusion Criteria:

- Treatment with any investigational agents within three months prior to or during the
study

- Treatment with systemic antibiotics, azulfidine, systemic corticosteroids, colchicine,
methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline,
tacrolimus, or vitamin E within three months prior to or during the study.

- Concomitant treatment with NSAIDS, antiplatelet agents, antihyperlipidemics, and
anticoagulant warfarin.

- Anticipated need for liver transplant within one year as determined by Mayo PSC risk
score (<80% one-year survival without transplant)

- Active drug or alcohol use

- Findings suggestive of liver disease of an alternative or concomitant etiology, such
as chronic alcoholic liver disease, chronic hepatitis B or C infection,
hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, non-alcoholic
steatohepatitis, primary biliary cirrhosis, or secondary sclerosing cholangitis (e.g.,
post-liver transplantation biliary stricture)

- Pregnancy or lactation

- Any condition that, in the opinion of the investigator, would interfere with the
patient's ability to complete the study safely or successfully.