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Rheumatoid ArthritisEarly Phase 1NCT00752154

Curcumin in Rheumatoid Arthritis

A Early Phase 1 study testing Curcumin (Longvida™) in people with Rheumatoid Arthritis, run by University of California, Los Angeles at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Curcumin (Longvida™)
Type of treatment
Pill or oral medicine
How many people
40 participants
Where
2 sitesUnited States
Study dates
Jan 2010to 1 Jan 2011
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

    Beverly Hills, California, 90042

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

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Curcumin in Rheumatoid Arthritis - ACross-Over Pilot Study

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.

Read more

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.

Being tested
Curcumin (Longvida™)
Keywords
Subjects, active, Rheumatoid, Arthritis, revised, American, College, Rheumatology, Criteria
Medical subject headings
Arthritis, Rheumatoid, Motor Activity, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Curcumin (Longvida™)Drug

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. American College of Rheumatology 20%

    Measured: 4 month period

Secondary outcomes (2)

  1. Inflammatory cell signaling markers

    Measured: 4 month

  2. Safety of curcumin

    Measured: 8 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2008 (estimated)
  2. Study startJan 2010
  3. Primary completion1 Dec 2010
  4. Study completion1 Jan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00752154
Sponsor's protocol ID
07-12-051
Status last verified
Sep 2008
First submitted
11 Sep 2008
Last updated
29 Sep 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Curcumin (Longvida™) in people with Rheumatoid Arthritis, run by University of California, Los Angeles at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

American College of Rheumatology 20% (time frame: 4 month period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00752154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.

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