Effect of Subcutaneous Polyvidone Collagen Treatment vs Placebo on Clinical Hand Recovery, Biochemical Response and Quality of Life in Adult Rheumatoid Arthritis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Effect of subcutaneous polyvidone collagen treatment on clinical hand recovery in adults with rheumatoid arthritis using the modified Kapandji Index, pain scale, and hand pressure strength.
研究概览
简要总结
A study in geriatric rheumatology on the treatment of rheumatoid arthritis (RA) in older adults is described. Its objective is to compare the effects of subcutaneous polyvidone collagen versus placebo, analyzing clinical improvement, biochemical response and quality of life in people over 60 years of age.
The Phase IV, double-blind, randomized, placebo-controlled clinical trial will be conducted between 2023 and 2026. Sixty patients with early-stage arthritis will participate, assessing factors such as pain, functionality and synovitis with various statistical tools and analyses.
详细描述
Geriatric rheumatology specializes in the study of rheumatic diseases in older adults, who have immune and physiological characteristics that influence the manifestation of these diseases. In the case of rheumatoid arthritis (RA), a chronic inflammatory disease that affects the joints, treatments that improve functionality and reduce pain in the hands, evaluated by ultrasound, are studied.
Its objective is to compare the effects of treatment with subcutaneous polyvidone collagen versus placebo on clinical improvement of the hands, biochemical response and quality of life in people over 60 years of age with rheumatoid arthritis.
A Phase IV, double-blind, randomized, placebo-controlled clinical trial will be conducted between August 2023 and August 2026. Sixty patients (30 in each group) with early-stage arthritis will participate. Pain, functionality, synovitis, and quality of life will be assessed using various scales, biochemical analyses, and statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with arthritic hand uni or bilateral
- •Early rheumatoid arthritis (> or equal to 2 years of evolution with treatment and stable)
- •Conventional treatment based on non-steroidal anti-inflammatory drugs (NSAIDs) alone for the disease without the use of biologic therapy or DMARDs.
排除标准
- •Patient with previous treatment of the arthritic hand with steroids, previous surgery and/or some other local medical treatment
- •Persistence of symptoms and functional alterations.
- •Patients with diabetes mellitus, rheumatic polyarthropathy, scleroderma, fibromyalgia, systemic lupus erythematosus or any other autoimmune disease.
研究组 & 干预措施
Case group
Patients with unilateral or bilateral arthritic hand, both genders, age of 60 years or older in treatment with subcutaneous polyvidone collagen.
干预措施: Subcutaneous polyvidone collagen (Drug)
Control group
Patients with unilateral or bilateral arthritic hand, both genders, age of 60 years or older
干预措施: saline solution (Other)
结局指标
主要结局
Effect of subcutaneous polyvidone collagen treatment on clinical hand recovery in adults with rheumatoid arthritis using the modified Kapandji Index, pain scale, and hand pressure strength.
时间窗: Every 15 days for 2 months
The clinical recovery of the hand in adults with rheumatoid arthritis will be evaluated by means of a modified Kapandji index, which consists of a test that allows evaluating the result of three different functions of the hand; the pain scale, where the patient is asked to observe the pain he/she feels and quantify it from 0 to 10, 0 being no pain and 10 being maximum pain; and the manual pressure force (MPF) where a maximum grip force is applied for a time of 3 seconds, with a rest of 1 minute between each repetition, making two attempts, measuring both times to obtain the best value.
次要结局
- Effect of subcutaneous polyvidone collagen treatment in quality of life in adult rheumatoid arthritis(2 months)
研究者
Clotilde Fuentes-Orozco
Principal Investigator
Instituto Mexicano del Seguro Social