Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
关键词
抽象
描述
See Brief Summary
日期
| 最后验证: | 07/31/2008 |
| 首次提交: | 11/12/2003 |
| 提交的预估入学人数: | 11/13/2003 |
| 首次发布: | 11/16/2003 |
| 上次提交的更新: | 08/21/2008 |
| 最近更新发布: | 08/24/2008 |
| 实际学习开始日期: | 10/31/2006 |
| 预计主要完成日期: | 04/30/2008 |
| 预计完成日期: | 10/31/2008 |
状况或疾病
干预/治疗
Drug: 1
Drug: 2
Drug: 3
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: 1 Fish Oil | Drug: 1 The object of this intervention is to determine whether treatment of rheumatoid arthritis with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. Each arm of the study will take 13 capsules daily (divided doses) for 18 months. |
| Active Comparator: 2 Borage Oil | Drug: 2 Borage oil 13 capsules divided doses daily for 18 months |
| Active Comparator: 3 Fish Oil and Borage Oil | Drug: 3 Fish oil and borage seed oil capsules - 13 capsules to be be taken daily (divided doses) for a period of 18 months |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria - 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 - Stable NSAID for 1 month before baseline if on an NSAID - Stable prednisone dose of < 10 mg/day for 1 month before baseline visit, if on prednisone - Ability to give and understand all elements of informed consent - Absence of comorbid condition which, in the opinion of the physician-investigator, would render the patient unsuitable for the study - Willingness to adhere to the clinical protocol. Exclusion Criteria - 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 - An inability or unwillingness to use an effective form of contraception (females) during the duration of the study - Pregnant and breast-feeding females - Inability or unwillingness to adhere to the study diet - Platelet count < 100,000/mm 3 - Hemoglobin < 9 g/dl - Albumin < 3.3 g |
结果
主要结果指标
1. The modified Disease Activity Score (DAS28) will be the primary outcome measure. [Assessed every 3 months]
次要成果指标
1. Reduction of other medication for RA [Assessed every 3 months]
