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临床试验/IRCT2015071623240N1
IRCT2015071623240N1已完成2 期

A randomized controlled trial to evaluate the slow acting symptom modifying effect of colchicine in patients with osteoarthritis of the knee

Investigator0 个研究点目标入组 81 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
81

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
35 years 至 75 years(—)
性别
All

入选标准

  • 1. American college of rheumatology (ACR) criteria and radiographic Kellgren & Lawrence criteria for osteoarthritis;
  • 2. Knee osteoarthritis;
  • 3. Non existence of Calcium pyrophosphate dihydrate crystal deposition disease (CPPD) arthritis in other joints;
  • 4. No History of gout and pseudo-gout;
  • 5. No History of inflammatory diseases according to laboratory;
  • 6. Non existence of liver, kidney, cardiovascular diseases, cardiomyopathy, moderate to severe neouropathy, GI problems, fibromyalgia, infection;
  • 7. No History of knee joint replacement;
  • 8. No concurrent use of drug interfering with colchicine;
  • 9. No existence of these laboratory tests:
  • White blood cells <3500/mm3
  • Hemoglobin <10 mg/dl
  • Creatinine >1.3 mg/dl
  • Amino transferase >45 IU
  • uric acid >6.5 mg/dl
  • 10. At least 2 months after intra-articular corticosteroids and 3 months after intra-articular hyaluronic acid;
  • 11. Using 2 weeks naproxen;
  • 12. At least 4-6 months after use of glucoseamine, chondroitine sulfate or methylsulfonylmethane (MSM);
  • 13. No contra-indication of colchicine;
  • 14. Co-operation.
  • Exclusion criteria:
  • 1. No use of drugs according to the study protocol;
  • 2. Severe side effect of colchicine or placebo;
  • 3. Aggravation of knee pain;
  • 4. Using analgesics due to other problems;
  • 5. Knee trauma or any other problems interfering with drug use in knee osteoarthritis;
  • 6. Loss of follow-up.

排除标准

  • 未提供

研究者

发起方
Investigator

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