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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02978339
Recruitment Status : Completed
First Posted : November 30, 2016
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
EuroPharma, Inc.
Information provided by (Responsible Party):
John E. Eaton, Mayo Clinic

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Sclerosing Cholangitis
Intervention Drug: Curcumin
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Curcumin
Hide Arm/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.

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.

Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Curcumin
Hide Arm/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.

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.

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 15 participants
46
(39 to 57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
8
  53.3%
Male
7
  46.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
Primary Sclerosing Cholangitis Duration  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 15 participants
9.00
(4 to 13)
Inflammatory Bowel Disease Present  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
10
  66.7%
1.Primary Outcome
Title Change in Serum Alkaline Phosphatase (SAP)
Hide Description Number of subjects who experience a reduction of Serum Alkaline Phosphatase (SAP) to less than 1.5 x Upper Limit of Normal or a 40% reduction between baseline and week 12.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin
Hide Arm/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.

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.

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
3
  20.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .03
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Change in Serum Aspartate Aminotransferase (AST)
Hide Description AST is an enzyme found in high amounts in liver, heart, and muscle cells. This test is mainly done along with other tests such as alkaline phosphatase and bilirubin to diagnose and monitor liver disease. This test evaluates hepatocyte integrity, as serum levels of this enzyme rise in response to a variety of forms of injury to hepatic cells. The normal range is 10 to 40 Unit/Liter (U/L)
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin
Hide Arm/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.

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.

Overall Number of Participants Analyzed 15
Median (Inter-Quartile Range)
Unit of Measure: U/L
78
(48 to 119)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in Total Bilirubin
Hide Description Bilirubin is a yellowish pigment found in bile, a fluid made by the liver. A small amount of older red blood cells are replaced by new blood cells every day. Bilirubin is left after these older blood cells are removed. The liver helps break down bilirubin so that it can be removed from the body in the stool. The normal range for total bilirubin is 0.3 to 1.9 milligrams/deciliter (mg/dL)
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin
Hide Arm/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.

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.

Overall Number of Participants Analyzed 15
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
0.6
(0.5 to 1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change in C-Reactive Protein (CRP)
Hide Description C-reactive protein is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 milligrams/Liter (mg/L)
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin
Hide Arm/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.

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.

Overall Number of Participants Analyzed 15
Median (Inter-Quartile Range)
Unit of Measure: mg/L
3.4
(1.5 to 9.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Change in Mayo Primary Sclerosing Cholangitis (PSC) Risk Score
Hide Description

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.

Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Twelve subjects completed questionnaires. Three subjects did not complete questionnaires
Arm/Group Title Curcumin
Hide Arm/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.

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.

Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0.54
(-0.17 to 0.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .15
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Change in Fatigue Severity
Hide Description Fatigue will be measured by a Modified Fatigue Impact Scale (MFIS). This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items. Subjects rate on a 5-point scale with 0 = never to 4 = almost always. The total score for the MFIS is the sum of the scores for the 21 items ranging from score of 0-84. Higher numbers indicate greater fatigue.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Twelve subjects completed questionnaires. Three subjects did not complete questionnaires.
Arm/Group Title Curcumin
Hide Arm/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.

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.

Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
8.00
(4.00 to 23.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .06
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Change in Pruritus
Hide Description Pruritus will be measured by the 5-D itch Scale. The 5-D itch scale was developed as a brief but multidimensional questionnaire designed to be useful as an outcome measure in clinical trials." The five dimensions are degree, duration, direction, disability and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items. All items of the first four domains were measured on a five-point Likert scale (1 = Not present/resolved/never, 5 = Unbearable/getting worse/always).The distribution domain included 16 potential locations of itch, including 15 body part items and one point of contact with clothing or bandages.The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus)
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Twelve of the subjects completed questionnaires. Three subjects did not complete questionnaires
Arm/Group Title Curcumin
Hide Arm/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.

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.

Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
8.00
(7.50 to 14.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .93
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse Events were collected for 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Curcumin
Hide Arm/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.

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.

All-Cause Mortality
Curcumin
Affected / at Risk (%)
Total   0/15 (0.00%)    
Hide Serious Adverse Events
Curcumin
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Curcumin
Affected / at Risk (%) # Events
Total   3/15 (20.00%)    
Gastrointestinal disorders   
Nausea   1/15 (6.67%)  1
General disorders   
Headache   1/15 (6.67%)  1
Investigations   
Blood Bilirubin increased   1/15 (6.67%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John E. Eaton, M.D.
Organization: Mayo Clinic
Phone: 507-284-3917
EMail: Eaton.John@mayo.edu
Layout table for additonal information
Responsible Party: John E. Eaton, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02978339    
Other Study ID Numbers: 14-002660
First Submitted: November 22, 2016
First Posted: November 30, 2016
Results First Submitted: December 13, 2019
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020