A randomized, double-blind, placebo-controlled parallel group study to evaluate the safety and comparative efficacy of investigational product BioSOLVECurcuminTM in patients with active Rheumatoid Arthritis in Knee, Hand and Neck.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To assess the comparative efficacy of investigational product BioSOLVECurcuminTM by the assessment of ACR-20, WOMAC scale and VAS in patients with active rheumatoid arthritis in knees, hands and neck.
研究概览
简要总结
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disorder that primarily affects various body joints and causes progressive destruction of articular structures, particularly, the cartilage and bone. Notably, the joint destruction is a prominent feature of the disease that not only distinguishes RA from other arthritic diseases but also determines its outcome in the majority of individuals affected. The long-term prognosis of RA is poor with as much as 80% of patients affected becoming disabled after 20 years and a concomitant reduction in life expectancy by an average of 3–18 years. If the disease remains untreated, 20–30% of patients may become permanently work-disabled within 2–3 yr of diagnosis. Predictors of poor outcome for RA include relatively low functional disease activity scores early in the disease progression, lower socio-economic status and education level, strong family history of the disease, and early involvement of many joints. Thirty per cent of the patients with severe forms of the disease typically remain unresponsive to any classic treatment intervention. Nonetheless, patients with milder forms of the disease may derive some level of benefit from early diagnosis and treatment.
In view of the overwhelming literature and promise for the potential benefits of curcumin- induced chemoprevention and treatment of several human diseases, the current study is a pilot effort to assess the efficacy and safety of BioSOLVECurcuminTM in comparison with placebo for 12 weeks in patients with active rheumatoid arthritis in knees, hands and neck. BioSOLVECurcuminTM is aspecially modified and formulated nutraceutical product with advantage of highly bioavailable curcumin for its intended pharmacological effect.
The main aim of the study is to investigate the effect of BioSOLVECurcuminTMin patients with active Rheumatoid Arthritis (RA) using subjective questionnaires as the evaluation parameters as well as assessment of the safety of the study product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group of 18-65 years, either male or female.
- •2.Diagnosis of RA according to the revised 2010 American College of Rheumatology (ACR) criteria (with RA functional class of II).
- •Total number of the Swollen Joint Count (SJC) and Tender Joint Count (TJC) should be greater than
- •3.Continuing or recurring pain (i.e joint pain daily, unless on pain medication).
- •Ability and willingness to participate in all components of the study
- •Patients who able to understand and sign written informed consent.
排除标准
- •Patients to whom one of following applies will be excluded: dysfunction of liver; severe cardiovascular, urinary, hematopoietic, or endocrine system disease; immunodeficiency; uncontrolled infection or active gastrointestinal tract disease; recent vaccination; gravida; women in lactation period or those recently intending to become pregnant; hypersensitivity to study product; treatment with any other disease-modifying anti-rheumatic drug (DMARD) or NSAIDS within 30 days before enrolment; history of alcohol abuse; history of hyperglycemia or motor coordination disorder; or participation in other clinical trials within 3 months before enrolment.
- •2.Patients with any surgical procedure, including bone or joint surgery or synovectomy within 12 weeks prior to screening.
- •3.Patients with significant systemic involvement of secondary RA (including diseases such as vasculitis, pulmonary fibrosis or Feltys syndrome), inflammatory joint disease other than RA (e.g. gout, psoriatic arthritis, seronegative spondyloarthropathy and Lyme disease)
- •Subjects with other systemic autoimmune disorder (e.g. systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap diseases.
结局指标
主要结局
To assess the comparative efficacy of investigational product BioSOLVECurcuminTM by the assessment of ACR-20, WOMAC scale and VAS in patients with active rheumatoid arthritis in knees, hands and neck.
时间窗: Baseline Visit Day 1,Day 30,Day 60, End of Visit (Day 90)
次要结局
- To assess the safety of investigational product BioSOLVECurcuminTM in active rheumatoid arthritis patients.(Baseline Visit Day 1,Day 30,Day 60, End of Visit (Day 90))