Trial Outcomes & Findings for A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC) (NCT NCT02978339)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

baseline, 12 weeks

Results posted on

2020-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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 Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Curcumin n=15 Participants 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.
Age, Continuous	46 years n=15 Participants
Sex: Female, Male Female	8 Participants n=15 Participants
Sex: Female, Male Male	7 Participants n=15 Participants
Region of Enrollment United States	15 participants n=15 Participants
Primary Sclerosing Cholangitis Duration	9.00 years n=15 Participants
Inflammatory Bowel Disease Present	10 Participants n=15 Participants

PRIMARY outcome

Timeframe: baseline, 12 weeks

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.

Outcome measures

Outcome measures
Measure	Curcumin n=15 Participants 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.
Change in Serum Alkaline Phosphatase (SAP)	3 Participants

SECONDARY outcome

Timeframe: Baseline, 12 weeks

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)

Outcome measures

Outcome measures
Measure	Curcumin n=15 Participants 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.
Change in Serum Aspartate Aminotransferase (AST)	78 U/L Interval 48.0 to 119.0

SECONDARY outcome

Timeframe: Baseline, 12 weeks

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)

Outcome measures

Outcome measures
Measure	Curcumin n=15 Participants 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.
Change in Total Bilirubin	0.6 mg/dL Interval 0.5 to 1.4

SECONDARY outcome

Timeframe: Baseline, 12 weeks

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)

Outcome measures

Outcome measures
Measure	Curcumin n=15 Participants 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.
Change in C-Reactive Protein (CRP)	3.4 mg/L Interval 1.5 to 9.1

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Twelve subjects completed questionnaires. Three subjects did not complete questionnaires

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.

Outcome measures

Outcome measures
Measure	Curcumin n=12 Participants 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.
Change in Mayo Primary Sclerosing Cholangitis (PSC) Risk Score	0.54 score on a scale Interval -0.17 to 0.63

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Twelve subjects completed questionnaires. Three subjects did not complete questionnaires.

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.

Outcome measures

Outcome measures
Measure	Curcumin n=12 Participants 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.
Change in Fatigue Severity	8.00 score on a scale Interval 4.0 to 23.0

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Twelve of the subjects completed questionnaires. Three subjects did not complete questionnaires

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)

Outcome measures

Outcome measures
Measure	Curcumin n=12 Participants 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.
Change in Pruritus	8.00 score on a scale Interval 7.5 to 14.5

Adverse Events

Curcumin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Curcumin n=15 participants at risk 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.
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • Adverse Events were collected for 12 weeks
General disorders Headache	6.7% 1/15 • Number of events 1 • Adverse Events were collected for 12 weeks
Investigations Blood Bilirubin increased	6.7% 1/15 • Number of events 1 • Adverse Events were collected for 12 weeks

Additional Information

John E. Eaton, M.D.

Mayo Clinic

Phone: 507-284-3917

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place