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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-09

Study Completion Date

2019-01-08

Brief Summary

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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).

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Detailed Description

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Conditions

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Primary Sclerosing Cholangitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Curcumin

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.

Group Type EXPERIMENTAL

Curcumin

Intervention Type DRUG

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.

Interventions

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Curcumin

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.

Intervention Type DRUG

Other Intervention Names

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CuraMed® softgel

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No