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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01759498
Enrollment
36
Registered
2013-01-03
Start date
2012-12-31
Completion date
2013-09-30
Last updated
2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Injuries

Keywords

Inflammation, Pain intensity, Flexibility, RICE protocol, Swelling

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTHYDRO
DIETARY_SUPPLEMENTACTIVE
DIETARY_SUPPLEMENTHYDRO 2

Sponsors

Center for Health Sciences, Serbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
change in serum C-reactive proteinevery week, up to 2 weeks

Secondary

MeasureTime frame
change in pain intensity during rest and walkingevery week, up to 2 weeks

Other

MeasureTime frame
change in degree of joint swellingevery week, up to 2 weeks
change in passive joint flexibilityevery week, up to 2 weeks
change in plasma viscosityevery week, up to 2 weeks
change in serum interleukin 6every week, up to 2 weeks

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026