IRCT2013111515408N1已完成3 期
Survey on oral administration of Nigella sativa L. on relieving clinical symptoms of knee osteoarthritis: a randomized double- blinded placebo-controlled clinical trial. Phase II: Evaluation of treatment response & safety of oral administration of nigella sativa.
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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
- 40 years 至 69 years（—）
- 性别
- All
入选标准
- •Inclusion criteria : Patients greater than 40 and less than 80 years old who have ACR clinical and radiological ACR criteria and VAS> 40mm after a drug wash out period . Radiological ACR criteria include : ? knee pain plus at least One of four following criteria ? ? 50 years of age, morning stiffness less than 30 minutes ? ?crepitus osteophytes. exclusion criteria : 1 . History of rheumatoid arthritis , gout , CPPD 2. Previous surgery on the affected knee 3 .Severe cardiovascular disease grade 3 and 4.4 . malignancy.5 . Liver disease ( bleeding esophageal varices , encephalopathy , ascites ) 6 . Symptomatic gallstone (in history ) 7 . Severe renal disease (serum creatinine 3 mg / dl) 8.administration of oral corticosteroid 4 weeks before 9 . More than 325 mg daily NSAID intake 10 . receiving any central nervous system depressant , including benzodiazepines , barbiturates and narcotics 11. Intra-articular treatment received 3 months ago.12 .Intaking Piaschledine or glucosamine . 13.Not tendency for drug taking. 14. Lack of willingness or ability of patients to complete the questionnaire used in the study. 15 . Older than 79 years .16. Pregnancy and lactation. 17 . patients with a history of asthma or respiratory allergies . 18. patients receiving insulin.19. . Patients receiving warfarin , clopidogrel 20 . Or any other medications that is not permitted , according to pharmacologist's view. 21 . Lack of persistence of above Nineteen . 22 . Patient's unwillingness to continue participation in the study. 23 . Occurrence of any of the threatening side effects that maybe don't predicted.
排除标准
- 未提供
研究者
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