Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- ACR20 Response Rate at 3 Weeks
研究概览
简要总结
Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis.
The molecular bases of this recommendation are not known, the investigators want to compare with the usage of high-throughput molecular technologies the variations occurring in patients treated with acupuncture and conventional treatment with the ones treated with conventional treatment only. The investigators observe the variations in blood and in the gut microbiome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The patient should be diagnosed as the first or second stage of rheumatoid Arthritis (RA) and checked with X ray for additional diagnose.
- •diagnosed for RA according to ACR(1987)
- •the patient should be in the active stage of the disease, defined as：
- •swollen joints >3
- •tender joints > 5
- •any one of the following： (c1.) morning stiffness lasting more than 45 minutes (c2.) Erythrocyte Sedimentation Rate (ESR) >= 28mm/h (c3.) C-reactive protein (CRP)>= 12mg/L
- •Should not be resistant to MTX nor leflunomide
- •Blood test should satisfy:
- •Hemoglobin (Hb)>=85g/L
- •White cell >=3.5 10+9/L
- •Platelets >= 100 10+9/L
- •Liver function: serum alanine aminotransaminase (ALT), aspartate transaminase (AST) and total bilirubin (TBil) should be less than 1.5 times the upper limit of normal (ULN)
- •Kidney function: Serum creatinine (Cr) level should be less than ULN.
- •Pregnancy test should be negative
- •should be positive for anti-cyclic citrullinated protein antibodies (anti-CCP).
- •should agree to sign the informed consent
排除标准
- •Serious diseases affecting liver, kidney, heart and lung, or diseases related to hematologic，endocrine and nervous systems. .
- •Be treated by MTX or Leflunomide in the last 3 months.
- •Be treated with cortical hormone （could be intramuscular injection, intravenous injection or injection to articular cavity） in the last 4 weeks.
- •Be treated with biological agents, such as antagonist of TNF-alpha,IL-6, and CD20 mono antibody in the last 3 months.
- •Be treated by chronic medicine, such as immunosuppressive agent, Penicillamine, chloroquine and gold based Disease-modifying antirheumatic drugs (DMARDs) in the last 3 months.
- •Pregnant and breast-feeding woman
- •Having history of serious drug allergy
- •In the acute or chronic phase of infection (such as lung diseases)
- •Easy bleeding patients or patients with local skin infection (only for acupuncture)
- •The patients cannot accept acupuncture (only for acupuncture)
- •Be treated with acupuncture in the past 3 months（only for acupuncture）.
- •No pregnant and breast-feeding woman.
- •No history of serious drug allergy.
研究组 & 干预措施
Acupuncture
Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
干预措施: methotrexate (Drug)
Acupuncture
Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
干预措施: non-steroidal anti-inflammatory drug (NSAID) (Drug)
Acupuncture
Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
干预措施: leflunomide (Drug)
Acupuncture
Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
干预措施: Acupuncture (Procedure)
Control
Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
干预措施: methotrexate (Drug)
Control
Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
干预措施: non-steroidal anti-inflammatory drug (NSAID) (Drug)
Control
Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
干预措施: leflunomide (Drug)
结局指标
主要结局
ACR20 Response Rate at 3 Weeks
时间窗: From baseline to 3 weeks
ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)
ACR20 Response Rate at 3 Months
时间窗: From baseline to three months
ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)
次要结局
- DAS28 at 3 Weeks(At 3 weeks)
- DAS28 at 3 Months(At 3 months)
- ACR50 Response Rate at 3 Weeks(From baseline to 3 weeks)
- ACR50 Response Rate at 3 Months(From baseline to three months)
- ACR70 Response Rate at 3 Weeks(From baseline to 3 weeks)
- DAS28 at Baseline(At baseline)
- ACR70 Response Rate at 3 Months(From baseline to three months)
研究者
Christine Nardini
Principal Investigator
Chinese Academy of Sciences