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

John E. Eaton

Status and phase: Completed; Phase 2; Phase 1

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: Curcumin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02978339

14-002660

Details and patient eligibility

About

The purpose of this study is to determine whether curcumin, a drug and naturally-occurring plant compound, is safe and effective in the treatment of primary sclerosing cholangitis (PSC).

Enrollment: 15 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Curcumin

Experimental group

Description:

Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin.

Treatment:

Drug: Curcumin