A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in improving pain of rheumatoid arthritis in adults
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- DAS-28 ESR Score
研究概览
简要总结
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by swelling of joints, joint tenderness and destruction of synovial joints, resulting in disability and untimely mortality. It is the most common inflammatory arthritis, affecting from 0.8% to 1% of the general population worldwide, with a female/male ratio of 3:1. The most common and predominant symptoms include joint pain and morning stiffness along with swelling. RA primarily involves small peripheral joints, usually of the hands. Axial joint involvement, is seen especially of the cervical region. We intend to undertake this research project to evaluate the efficacy of homoeopathic medicines in the treatment of RA in adults. A double blind, randomized (2:1),placebo-controlled trial will be conducted on 51 patients who are suffering from RA at the outpatient department of D.N. De Homoeopathic Medical College and Hospital. Primary outcome measure is DAS-28 ESR score; secondary outcomes are DAS-28 CRP, CDAI, SDAI and MYMOP-2. DAS-28 ESR, DAS-28 CRP, CDAI and SDAI to be measured at baseline and after 3 months. MYMOP-2 will be measured at baseline, every month, up to 3 months. Comparative analyses will be carried out to detetct group differences. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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 suffering from rheumatoid arthritis (M06.9) for 3 months or more, diagnosis confirmed through the criteria given by the 2010 American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) Number and site of involved joints.
- •2 to 10 large joints: 1 point (shoulders, elbows, hips, knees, and ankles) 1 to 3 small joints: 2 points (metacarpophalangeal joints, proximal interphalangeal joints, second through fifth metatarsophalangeal joints, thumb interphalangeal joints, and wrists) 4 to 10 small joints: 3 points Greater than 10 joints (including at least 1 small joint): 5 points Serological testing for rheumatoid factor[RA] or anti-citrullinated peptide/protein antibody [ACPA] at least one test is needed for classification Low positive: 2 points High positive: 3 points Acute phase reactants (at least one test result is needed for classification) Negative erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP]: 0 point Elevated acute phase reactant [ESR] or C-reactive protein [CRP]:1 point Symptom duration at least six weeks: 1 point. A total score of greater than or equal to 6 classifies the patient as having RA.
- •DAS-28 ESR score between 2.6 and less than 3.2 (low disease activity) and between 3.2 and 5.1 (moderate disease activity).
- •Age between 18 and 65 years
- •Patients of either sex including transgender, if any.
- •Literate patients; ability to read English and/or Bengali, hindi, Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.
- •Providing written informed consent voluntarily.
- •Patients with known but controlled systemic diseases are also eligible for the study.
排除标准
- •Cases with complication showing extra articular features like digital arteritis, pericarditis, cervical cord compression etc
- •Apparently Similar resembling disease conditions; e.g., idiopathic osteoarthritis, systemic lupus erythematosus, psoriatic arthritis.
- •Vulnerable population- unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, institutionalized subjects, mentally incompetent people.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
- •Pregnant and puerperal women, lactating mothers
- •Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence
- •Self-reported immune-compromised state
- •Already undergoing homoeopathic treatment for chronic disease within last 6 months.
- •Simultaneous participation in any other trials.
结局指标
主要结局
DAS-28 ESR Score
时间窗: At baseline, and after 3 months
次要结局
- DAS-28 CRP(At baseline, and after 3 months)
- Clinical disease activity index (CDAI) and simple disease activity index (SDAI)(At baseline, and after 3 months)
- Measure Yourself Medical Outcome Profile (MYMOP-2)(At baseline, every month, up to 3 months)