CTRI/2022/08/044883已完成未知
A Double Blind, Single Centric, Randomized Placebo-Controlled Study to Demonstrate The Efficacy And Tolerability Of An Oral Treatment In The Management Of Oedema In Acute Tibio-Peroneal-Talar Sprain In Comparison To Placebo.
International Health Science Srl0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 90
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 male or female subjects (age 30-50 yrs).
- •2. Adult subjects with acute ankle sprain (grade I or II)
- •3. Able to communicate adequately with the investigator and
- •to comply with the requirements for the entire study
- •4. Patient should be able to give written informed consent prior to
- •participating in the study
排除标准
- •1. Steroidal anti-inflammatory drugs, NSAIDs.
- •2. Hypersensitivity to any components of the investigational dietary
- •supplement.
- •3. Fractures (ankle and joints) diagnosed at RX.
- •4. Grade 3 sprain (near total loss of function, positive anterior drawer
- •and talus tilt tests, extensive bruising / haemorrhage, great insertional
- •pain, joint limitation > 10 °, edema > 2.0 cm).
- •5. Concomitant diseases (i.e. cancer, kidney diseases, liver diseases,
- •neurological diseases, psychiatric diseases, blood disorders,
- •gastrointestinal diseases).
- •6. Treatment with anticoagulants and Diuretics.
- •7. Pregnancy and breastfeeding women.
- •8. Participation in concomitant interventional clinical study or during
- •the previous 30 days.
研究者
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