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A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)
Phase 1 & 2
Waitlist Available
Led By Nicholas F LaRusso, M.D.
Research Sponsored by John E. Eaton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
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).
Eligible Conditions
- Primary Sclerosing Cholangitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Serum Alkaline Phosphatase (SAP)
Secondary study objectives
Change in C-Reactive Protein (CRP)
Change in Fatigue Severity
Change in Mayo Primary Sclerosing Cholangitis (PSC) Risk Score
+3 moreSide effects data
From 2023 Phase 4 trial • 58 Patients • NCT042059293%
Migraine headache
3%
Stomach cramps
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group
Curcumin Group
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CurcuminExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Curcumin
FDA approved
Find a Location
Who is running the clinical trial?
John E. EatonLead Sponsor
EuroPharma, Inc.Industry Sponsor
8 Previous Clinical Trials
614 Total Patients Enrolled
Nicholas F LaRusso, M.D.Principal InvestigatorMayo Clinic