Suspended
Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
What is being tested
fish oil
+ borage seed oil
+ combination fish oil and borage seed oil
Drug
Who is being recruted
Arthritis+6
+ Arthritis, Rheumatoid
+ Autoimmune Diseases
From 18 to 85 Years
+19 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: November 2006
Summary
Principal SponsorNational Center for Complementary and Integrative Health (NCCIH)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2006
Actual date on which the first participant was enrolled.See Brief Summary
Official TitleTreatment of Rheumatoid Arthritis With Marine and Botanical Oils
Principal SponsorNational Center for Complementary and Integrative Health (NCCIH)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
156 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
ArthritisArthritis, RheumatoidAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue Diseases
Criteria
9 inclusion criteria required to participate
Definite RA with onset at > 16 years, with total disease duration of at least 6 months
Active disease as manifested by at least 3 joints that are swollen and 6 joints that are tender at time of enrollment, and either an erythrocyte sedimentation rate >_28, or a CRP >1.4, or morning stiffness of at least 45 min
Stable dose of DMARDs for 2 mos before baseline visit, with total duration of DMARD for 6 mos.
All standard therapy for RA, including DMARDs and combinations of DMARDs will be allowed as long as doses have been stable for 2 mos
Show More Criteria
10 exclusion criteria prevent from participating
A diagnosis of inflammatory arthritis other than rheumatoid arthritis
Chronic anticoagulation
Hypersensitivity to fish or fish products or plant products
A dose of prednisone of > 10 mg/day, or either a change in the prednisone dose or intra-articular corticosteroid injection within one month of the baseline evaluation
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorFish Oil
Group II
Active ComparatorBorage Oil
Group III
Active ComparatorFish Oil and Borage Oil
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
Suspended
UAB Arthritis Clinical Intervention Program
Birmingham, United StatesOpen UAB Arthritis Clinical Intervention Program in Google MapsSuspended
New England Res. Associates
Trumbull, United StatesSuspended
RASF Clinical Research Center
Boca Raton, United StatesSuspended
Lake Rheumatology
Tavares, United StatesSuspended13 Study Centers