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
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 4
- 主要终点
- Recovery from the injury, assessed by the Global score of the evaluated parameters of inflammation.
研究概览
简要总结
This is a randomized, double blind, parallel group, multi-centre trial comparing the efficacy and safety of a combination of trypsin-chymotrypsin enzymes plus diclofenac (TCD) and diclofenac alone in the management of inflammation due to soft tissue injuries. A total of 200 patients are proposed to be enrolled at 4 centres in India. The anticipated date of enrollment of patients is October 25, 2009. The primary end-point of the study will be recovery from the injury, assessed by the global score of the evaluated parameters of inflammation. The secondary end-point will be relief of individual symptoms of inflammation such as pain, swelling and restriction of movement assessed by individual symptom scores.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
入选标准
- •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 consent4)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:
- •Clean Lacerated Wounds (non infected) requiring suturing.2.Patients with healed fractures more than 3 months old.
排除标准
- •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.
- •Post operative cases5)Patients who have Diabetes/ Raised Blood Sugar6)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.
结局指标
主要结局
Recovery from the injury, assessed by the Global score of the evaluated parameters of inflammation.
时间窗: End of study
次要结局
- Relief of individual symptoms of inflammation assessed by the individual symptom score for pain, swelling and restriction of movement(End of study)