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临床试验/NCT01759498
NCT01759498已完成2 期

The Effects of Hydrogen-rich Formulation for Treatment of Sport-related Soft Tissue Injuries

Center for Health, Exercise and Sport Sciences, Serbia2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2012年12月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
change in serum C-reactive protein

研究概览

简要总结

Since hydrogen therapy in humans seems to be beneficial for treating inflammation, ischemia-reperfusion injury and oxidative stress, it seems plausible to evaluate the effects of exogenously administered hydrogen as an element of instant management of sport-related soft tissue injuries (e.g. muscle sprain, ligament strain, tendonitis, contusion). The main aim of the present study will be to examine the effects of two-week hydrogen-rich oral and topical administration on the inflammation, recovery and functional abilities in competitive male and female athletes after acute soft-tissue injury. During the season 2012/2013 (from February to June) subjects (36 professional athletes) will be recruited and examined by certified sports medicine specialist in the out-patient clinics of the Center for Health, Exercise and Sport Sciences in the first 24 hours after the sport-related soft tissue injury was sustained. The subjects will be allocated to a double-blind design to three randomly assigned trials. During the period of 2 weeks subjects in the placebo group (PLA) will receive traditional treatment protocol after the soft-tissue injury, consisting of RICE protocol during the first 48 h and sub-acute protocol thereafter. Subjects in the first experimental group will follow the above procedures with additional administration of oral hydrogen-rich capsules (4 capsules three times per day) throughout the study. Subjects in the second experimental group will follow the procedures of first experimental group with additional administration of hydrogen-rick packs 6 times per day for 20 minutes throughout the study. Participants will be evaluated at the beginning of the study (e.g. at the time of the injury report), after 7 and 14 days after baseline testing for: a) serum C-reactive protein, plasma viscosity and interleukin 6 level, b) pain intensity during rest and walking, c) degree of joint swelling, d) passive joint flexibility, and, e) subjective side-effects. The investigators expect that the administration of hydrogen will significantly improve inflammation outcomes (e.g. decrease in serum C-reactive protein) as compared to the placebo, with topical hydrogen administration will additionally improve post-injury recovery outcomes (e.g. pain intensity, degree of swelling). These results could support the hypothesis that hydrogen-rich intervention may be included as an element of immediate treatment for sport-related soft tissue injuries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • recent history of acute soft-tissue sports injury
  • professional athletes

排除标准

  • not ambulatory patients
  • clinical findings classed as more severe than grade II

结局指标

主要结局

change in serum C-reactive protein

时间窗: every week, up to 2 weeks

次要结局

  • change in pain intensity during rest and walking(every week, up to 2 weeks)

研究者

发起方
Center for Health, Exercise and Sport Sciences, Serbia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Assoc. Prof. Sergej M. Ostojic, MD, PhD

Head of Human Performance Laboratory

Center for Health, Exercise and Sport Sciences, Serbia

研究点 (2)

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