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The Effects of Hydrogen-rich Formulation for Treatment of Sport-related Soft Tissue Injuries
ClinicalTrials.gov Identifier:

This study has been completed.

NCT01759498

Sponsor:

Center for Health, Exercise and Sport Sciences, Serbia

Information provided by (Responsible Party):

Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia
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First received: December 25, 2012

Last updated: September 27, 2013
Last verified: September 2013
History of Changes

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Purpose
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 hydrogenrich oral and topical administration on the inflammation, recovery and functional abilities in competitive male and female athletes after acute softtissue 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.

Condition

Intervention

Phase

Soft Tissue Injuries

Dietary Supplement: HYDRO

Dietary Supplement: ACTIVE
Dietary Supplement: HYDRO 2

Phase 2

Study Type:

Interventional

Study Design:

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Edema Exercise and Physical Fitness

U.S. FDA Resources
Further study details as provided by Center for Health, Exercise and Sport Sciences, Serbia:

Primary Outcome Measures:

change in serum C-reactive protein [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
change in pain intensity during rest and walking [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
Other Outcome Measures:
change in degree of joint swelling [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
change in passive joint flexibility [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
change in plasma viscosity [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
change in serum interleukin 6 [ Time Frame: every week, up to 2 weeks ] [ Designated as safety issue: No ]
Enrollment:
Study Start Date:
Study Completion Date:
Primary Completion Date:

36
December 2012
September 2013
June 2013 (Final data collection date for primary outcome measure)

Assigned
Interventions

Arms

Experimental: HYDRO 2
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.
Active Comparator: ACTIVE
During the period of 2 weeks subjects will receive traditional treatment protocol after the soft-tissue injury, consisting of RICE
protocol during the first 48 h (e.g. rest, ice packs for 20 minutes every 2 hours, compression with elastic bandage, elevation of
the injured area above the level of the heart at all possible times) and sub-acute protocol thereafter (e.g. passive stretching 3
times per day for 90 sec, isometric strength exercise with 3 sets with 15 repetitions, 30 min of pain-free weight-bearing
exercise).
Experimental: HYDRO
Subjects in the first experimental group will follow the PLA procedures with additional administration of oral hydrogen-rich
capsules (4 capsules three times per day) throughout the study.

Dietary
Supplement:
HYDRO 2
Dietary
Supplement:
ACTIVE

Dietary
Supplement:
HYDRO

Eligibility
Ages Eligible for Study:
Genders Eligible for Study:
Accepts Healthy Volunteers:

18 Years to 30 Years
Both
Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a
study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general
information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759498

Locations
Serbia

Center for Health, Exercise and Sport Sciences

Belgrade, Serbia, 11000
Sponsors and Collaborators

Center for Health, Exercise and Sport Sciences, Serbia

Investigators

Principal Investigator:

Sergej M Ostojic, MD, PhD

Center for Health, Exercise and Sport Sciences

More Information
Additional Information:
Related Info
Publications:
Ostojic SM. Serum alkalinization and hydrogen-rich water in healthy men. Mayo Clin Proc. 2012 May;87(5):501-2. doi:
10.1016/j.mayocp.2012.02.008.
Jackson MJ. Free radicals generated by contracting muscle: by-products of metabolism or key regulators of muscle function? Free Radic Biol Med.
2008 Jan 15;44(2):132-41. doi: 10.1016/j.freeradbiomed.2007.06.003. Epub 2007 Jun 13. Review.
Ohno K, Ito M, Ichihara M, Ito M. Molecular hydrogen as an emerging therapeutic medical gas for neurodegenerative and other diseases. Oxid Med
Cell Longev. 2012;2012:353152. doi: 10.1155/2012/353152. Epub 2012 Jun 8. Review.
Responsible Party:
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Assoc. Prof. Sergej M. Ostojic, MD, PhD, Head of Human Performance Laboratory, Center for Health, Exercise and
Sport Sciences, Serbia
NCT01759498 History of Changes
012-12C/4, RPP-3
December 25, 2012
September 27, 2013
Serbia: Ethics Committee

Keywords provided by Center for Health, Exercise and Sport Sciences, Serbia:
Inflammation
Pain intensity
Flexibility
RICE protocol
Swelling
Additional relevant MeSH terms:
Soft Tissue Injuries
Wounds and Injuries
ClinicalTrials.gov processed this record on January 21, 2015