ACTRN12608000468325招募中2 期
An evaluation of efficacy of treatment of osteoarthritis of the knee with Chinese herbal medicine will be conducted in a placebo-controlled, oral-administration randomised clinical trial, and assessed by the Western Ontario and Mc Masters Universities (WOMAC) oseoarthritis index score.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Unilateral or bilateral osteoarthritis (OA) of the knee and fulfil the criteria provided the American College of Rheumatology (ACR) 1995 (ACR) will be eligible to participate. The ACR criteria are: knee pain and radiographic osteophytes and at least one of the following three items:
- •a. age > 50 years;
- •b. morning stiffness = 30 minutes in duration;
- •c. crepitus on motion.
- •2. Radiographic evidence of OA will be based on the Kellgren-Lawrence radiographic system (either grade II or grade III severity primary tibio-femoral OA as a condition of inclusion).
- •3. Fluent in the English language or able to give informed consent and complete study assessments with the assistance of an interpreter.
- •4. Provide written informed consent to participate in the study and be willing to comply with the study procedures.
- •5. No abnormal finding of clinical relevance at the screening evaluation.
排除标准
- •1. Accompanying osteoarthritis (OA) of hip of sufficient severity to interfere with the functional assessment of the knee.
- •2. Secondary OA or rheumatoid inflammatory or any other type of arthritis.
- •3. Previous and ongoing treatment with oral symptomatic slow acting drugs in OA (SYSADOA) treatment within 2 months before the study (e.g. glucosamine sulphate, chondroitin sulphate, diacerein, piascledine).
- •4. Requiring arthroplasty within 2 months or anticipating any need for a surgical procedure on the involved joint during the study.
- •5. Have received intra-articular treatment of the involved joint or joint lavage in the previous 6 months (e.g., corticosteroids or hyaluronic acid).
- •6. Knee surgery during the previous 3 months.
- •7. Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs).
- •8. Taking any regular prescribed medicine for OA during the trial except for medications pain that are taken ‘as required’ for break-through pain.
- •9. Any significant systemic illnesses or medical conditions that could lead to difficulty complying with the protocol;
- •10. Screening or baseline liver function tests Serum Glutamic Oxaloacetic Transaminase (SGOT), Aspartate Aminotransferase (AST) and/or Serum Glutamic Pyruvic Transaminase (SGPT), Alanine Aminotransferase (ALT) >2.5 times the upper limits of laboratory reference range.
- •11. Any additional condition(s) that, in the investigator’s opinion, would prohibit the subject from completing the study, or not be in the best interest of the subject.
- •12. Pregnancy or active breast-feeding. Female subjects of childbearing potential (not postmenopausal for at least 1year or surgically sterilized) must agree not to become pregnant during the duration of the study. Specifically, they must agree to use an appropriate contraceptive regimen.
- •13. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel, electrolytes including sodium (Na+) and potassium (K+), and urinalysis).
- •14. Evidence of clinically relevant, cardiovascular, haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic or psychiatric disorder.
- •15. Use of any over the counter product medications, herbal products, diet aids, hormone supplements, etc., within 14 days prior to dosing unless approved by both the Principal Investigator.
- •16. Use of any medication outlined in section 9.2.
- •17. Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to inclusion.
- •18. Unwilling or unable to provide written informed consent.
研究者
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