CTRI/2009/091/000813已完成3 期
A randomized, double blind, comparative, parallel-group clinical trial to evaluate the efficacy and safety of a combination of trypsin-chymotrypsin enzymes and diclofenac (TCD) in comparison to diclofenac alone in the management of inflammation due to soft tissue injuries
Elder Pharmaceuticals Ltd.,C-9, Dalia Industrial Estate, Veera Desai Road, Off New Link Road,Andheri (W), Mumbai ? 53.0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
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
入选标准
- •1)Adult patients aged between 18 and 65 years with soft tissue injuries like sprains, strains, stress injuries, ecchymosis, hematomas and lacerations seen within 24 hours of the injury
- •2)Patients aged between 18 and 65 years.
- •3)Patients who have given their written informed consent
- •4)Patients of childbearing years who are using appropriate contraceptive methods for 3 weeks prior to the study and throughout the duration of the study.
- •The following patients may also be included:
- •1. Clean Lacerated Wounds (non infected) requiring suturing.
- •2.Patients with healed fractures more than 3 months old
排除标准
- •1)Any long standing/ chronic inflammatory condition like Rheumatoid Arthritis, Osteoarthritis or Spondylitis where the patient has been on long term NSAIDs, Anti-Inflammatory drugs or Analgesics.
- •2)Infected wounds, Tissue abscesses and Cellulitis
- •3)Patients with Fracture if less than 3 months old.
- •4)Post operative cases
- •5)Patients who have Diabetes/ Raised Blood Sugar
- •6)Pregnant or breast-feeding women.
- •7)Patients who are simultaneously participating in another clinical trial with an unlicensed drug or who have done so within a one month period.
- •8)Patients with a known hypersensitivity to TC or Diclofenac
研究者
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