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Completed

NCT Number: NCT01759498

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

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Health, Exercise and Sport Sciences

Belgrade, 11000, Serbia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

HYDRO

Dietary Supplement

Active

Dietary Supplement

HYDRO 2

Dietary Supplement

Primary outcomes

  1. change in serum C-reactive protein

    Time frame: every week, up to 2 weeks

Secondary outcomes

  1. change in pain intensity during rest and walking

    Time frame: every week, up to 2 weeks

Other outcomes

  1. change in degree of joint swelling

    Time frame: every week, up to 2 weeks

  2. change in passive joint flexibility

    Time frame: every week, up to 2 weeks

  3. change in plasma viscosity

    Time frame: every week, up to 2 weeks

  4. change in serum interleukin 6

    Time frame: every week, up to 2 weeks

Sponsors and collaborators

Lead sponsor

Center for Health Sciences, Serbia

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 3, 2013
Registry last updated
Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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