Back to results

Curcumin in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Curcumin (Longvida™)

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Subjects, active, Rheumatoid, Arthritis, revised, American, College, Rheumatology, Criteria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years; read and understand English
Stable dose of non-steroidal anti-inflammatory agents (NSAID) for ≥ 2 weeks.
Oral prednisone or equivalent ≤ 10 mg daily and stable dose for ≥ 2 weeks(and must be kept stable throughout the duration of the protocol).
- ESR > 20 mm/hr, or CRP > 0.8 mg/dl
May be using any of the following DMARDs: methotrexate, sulfasalazine, hydroxychloroquine or leflunomide. If using any of these DMARDs must be using them for ≥ 12 weeks and stable dose for ≥ 4 weeks. If using other DMARD, or DMARD combinations, these additional or other DMARDs must be stopped for ≥ 4 weeks before baseline visit. May also participate if patient not on DMARD,
Subjects must be diagnosed with rheumatoid arthritis based on the revised American College of Rheumatology criteria:Presence of > swollen and > 6 tender joint count (28 joint count), and either ESR > 20 mm/hr or CRP > 0.8 mg/dl

Exclusion Criteria:

Acute medical conditions deemed as inappropriate by the investigators (acute heart failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
AST/ALT > 1.5 upper limit of normal (ULN)
Serum creatinine > 1.6 mg/dl
Hemoglobin/Hematocrit < 10.0 gram/dl/ 30.0
Platelet count < 100,000
Current use of warfarin (as there is a drug interaction between curcumin and warfarin).
Currently on biologic therapy (must have stopped etanercept for ≥ 4 weeks or adalimumab or infliximab for ≥ 8 weeks at time of Time 1 visit),
Women who are pregnant,
Subjects who are taking digoxin, warfarin and/or heparin,
Subjects with a history of antiphospholipid syndrome and other thrombophilic states,
Subjects who have an INR >= 1.5 at baseline,
Subjects with acute episode(s) of cholecystitis within the last 6 months,
Subjects with active peptic ulcer disease within the last 6 weeks

Sites / Locations

Swamy Venuturpualli, M.D., 8737 Beverly Blvd., #203
UCLA, 1000 Veteran Avenue, Rehab Building, 3rd Floor

Outcomes

Primary Outcome Measures

American College of Rheumatology 20%

Secondary Outcome Measures

Inflammatory cell signaling markers

Safety of curcumin

Full Information

NCT ID

NCT00752154

First Posted

September 11, 2008

Last Updated

September 27, 2023

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT00752154

Brief Title

Curcumin in Rheumatoid Arthritis

Official Title

Curcumin in Rheumatoid Arthritis - ACross-Over Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

January 2010 (Actual)

Primary Completion Date

December 1, 2010 (Actual)

Study Completion Date

January 1, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Curcuma longa or turmeric is a tropical plant native to south and southeast tropical Asia. Perhaps the most active component in turmeric is curcumin which may make up 2-5% of the total spice in turmeric. The study drug being tested in this study is curcumin. This study is called a cross-over study because all subjects will receive the study drug for a certain amount of time and then switch to placebo (an inactive substance) for a certain time or vice versa. The subject's participation may last up to 8 months. The subject will be randomized (by chance; like flipping a coin) to receive either the study drug, curcumin, or placebo for 4 months. After 4 months, if the subject was taking curcumin they will stop taking it and begin to take placebo and if the subject was taking placebo they will stop taking it and begin taking curcumin for the remaining 4 months. By completion of the study, all 40 subjects will have taken curcumin and placebo for 4 months each. Curcumin/placebo will be provided in capsule form and the subject will take it by mouth. The dose dose will be increased every week for up to a total of 4 grams per day. Subjects will have blood tests, complete questionnaires, and be seen by the study doctor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Subjects, active, Rheumatoid, Arthritis, revised, American, College, Rheumatology, Criteria

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Curcumin (Longvida™)

Intervention Description

Curcumin (Longvida™) or matching placebo. They will begin by taking 4 capsules (approximately 2 grams) once a day for 2 weeks and then the dose will be increased to 4 capsules twice a day (4 gram per day) beginning at week 3. Subjects will remain at this dose for an additional 13 weeks for a total 16 weeks. After 16 weeks, the same procedures will be repeated for another 16 weeks

Primary Outcome Measure Information:

Title

American College of Rheumatology 20%

Time Frame

4 month period

Secondary Outcome Measure Information:

Title

Inflammatory cell signaling markers

Time Frame

4 month

Title

Safety of curcumin

Time Frame

8 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years; read and understand English Stable dose of non-steroidal anti-inflammatory agents (NSAID) for ≥ 2 weeks. Oral prednisone or equivalent ≤ 10 mg daily and stable dose for ≥ 2 weeks(and must be kept stable throughout the duration of the protocol). ESR > 20 mm/hr, or CRP > 0.8 mg/dl May be using any of the following DMARDs: methotrexate, sulfasalazine, hydroxychloroquine or leflunomide. If using any of these DMARDs must be using them for ≥ 12 weeks and stable dose for ≥ 4 weeks. If using other DMARD, or DMARD combinations, these additional or other DMARDs must be stopped for ≥ 4 weeks before baseline visit. May also participate if patient not on DMARD, Subjects must be diagnosed with rheumatoid arthritis based on the revised American College of Rheumatology criteria:Presence of > swollen and > 6 tender joint count (28 joint count), and either ESR > 20 mm/hr or CRP > 0.8 mg/dl Exclusion Criteria: Acute medical conditions deemed as inappropriate by the investigators (acute heart failure, uncontrolled diabetes mellitus, uncontrolled hypertension) AST/ALT > 1.5 upper limit of normal (ULN) Serum creatinine > 1.6 mg/dl Hemoglobin/Hematocrit < 10.0 gram/dl/ 30.0 Platelet count < 100,000 Current use of warfarin (as there is a drug interaction between curcumin and warfarin). Currently on biologic therapy (must have stopped etanercept for ≥ 4 weeks or adalimumab or infliximab for ≥ 8 weeks at time of Time 1 visit), Women who are pregnant, Subjects who are taking digoxin, warfarin and/or heparin, Subjects with a history of antiphospholipid syndrome and other thrombophilic states, Subjects who have an INR >= 1.5 at baseline, Subjects with acute episode(s) of cholecystitis within the last 6 months, Subjects with active peptic ulcer disease within the last 6 weeks

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dinesh Khanna, M.D.

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

Swamy Venuturpualli, M.D., 8737 Beverly Blvd., #203

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90042

Country

United States

Facility Name

UCLA, 1000 Veteran Avenue, Rehab Building, 3rd Floor

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Curcumin in Rheumatoid Arthritis

We'll reach out to this number within 24 hrs