Clinical Trial: A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: An Open-Label Pilot Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis
Brief Summary: 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).
Detailed Summary:
Sponsor: Nicholas LaRusso
Current Primary Outcome:
- Proportion of Subjects Who Experience a 40% Reduction in Serum Alkaline Phosphatase (ALP) [ Time Frame: 12 weeks ]
- Proportion of Subjects Who Experience a Decrease in Serum ALP to Less than 1.5 times the Upper Level of Normal [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mean Change in Serum Aspartate Aminotransferase (AST) [ Time Frame: Baseline, 12 weeks ]
- Mean Change in Total Bilirubin [ Time Frame: Baseline, 12 weeks ]
- Mean Change in Albumin [ Time Frame: Baseline, 12 weeks ]
- Mean Change in C-Reactive Protein [ Time Frame: Baseline, 12 weeks ]
- Mean Change in Mayo PSC Risk Score [ Time Frame: Baseline, 12 weeks ]
The Mayo Risk Score (R) = (0.0295 * (age in years)) + (0.5373 * natural logarithm(total bilirubin in mg/dL)) - (0.8389 * (serum albumin in g/dL)) + (0.5380 * natural logarithm(AST in IU/L) + (1.2426 * (points for variceal bleeding)) where:
AST = serum aspartate aminotransferase level, Points for variceal bleeding: 0 if none, 1 if present. Each unit increase in the Mayo Risk Score (R) is associated with a 2.5-fold increase in the risk of death. Most references to the score round the coefficients to 2 decimal places. The score shows very slight upward slope over time in stable patients, but during the terminal phase it shows an acceleration in progression.
- Mean Change in Self-Reported Health Status [ Time Frame: Baseline, 12 weeks ]Health Status will be measured by a linear Visual Analog Scale (VAS) ranging from 0 (as bad as it can be) to 10 (as good as it can be).
- Mean Change in Fatigue Severity [ Time Frame: Baseline, 12 weeks ]Fatigue will be measured by a linear Visual Analog Scale (VAS) ranging from 0 (as bad as it can be) to 10 (as good as it can be).
- Mean Change in Pruritus [ Time Frame: Baseline, 12 weeks ]Pruritus will be measured by a linear Visual Analog Scale (VAS) ranging from 0 (as bad as it can be) to 10 (as good as it can be).
Original Secondary Outcome: Same as current
Information By: Mayo Clinic
Dates:
Date Received: November 22, 2016
Date Started: May 2017
Date Completion: June 2018
Last Updated: May 11, 2017
Last Verified: May 2017