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Marine and Botanical Oils
1 for Rheumatoid Arthritis
Phase 3
Waitlist Available
Led By Robert B Zurier, MD
Research Sponsored by National Center for Complementary and Integrative Health (NCCIH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Summary
The object of this study is to determine whether treatment of rheumatoid arthritis (RA) with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. This study will also investigate the biochemical, immunological, and molecular mechanism responsible for the therapeutic effects of these fatty acids. Each patient will be followed for eighteen months.
Eligible Conditions
- Rheumatoid Arthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Active Control
Group I: 1Active Control1 Intervention
Fish Oil
Group II: 3Active Control1 Intervention
Fish Oil and Borage Oil
Group III: 2Active Control1 Intervention
Borage Oil
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Who is running the clinical trial?
National Center for Complementary and Integrative Health (NCCIH)Lead Sponsor
853 Previous Clinical Trials
671,584 Total Patients Enrolled
7 Trials studying Rheumatoid Arthritis
434 Patients Enrolled for Rheumatoid Arthritis
Robert B Zurier, MDPrincipal InvestigatorUniversity of Massachusetts, Worcester
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