NCT06217549

Brief Summary

The goal of this clinical trial is to investigate the effect of the ozone therapy applied using the major autohemotherapy method on exercise performance in male healthy individuals. The main question's aims to answer are:

  • Is ozone therapy applied with the major autohemotherapy method increase the performance?
  • Is ozone therapy applied with the major autohemotherapy method improve the recovery after exercise?
  • Participants are asked to continue the same exercise program throughout the study. They were given 10 sessions of ozone therapy over 6 weeks. Researchers compared the before and after treatment performance and recovery data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 9, 2024

Last Update Submit

January 22, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • VO2max

    maximum oxygen consumption, indicator of aerobic capacity, cardiopulmonary exercise tests performed twice for each participant

    just before the first ozone therapy session and immediately after the last ozone therapy session

  • exercise duration

    duration of cardiopulmonary exercise test

    just before the first ozone therapy session and immediately after the last ozone therapy session

  • Modified Borg Scale

    Modified Borg Scale is used to measure the perceived fatigue level. The participants were asked to rate their perceived fatigue on a scale of 1-10. It was expressed as 1 'no fatigue' and 10 'extreme fatigue (exhaustion).

    just before the first ozone therapy session and immediately after the last ozone therapy session

  • Lactate levels

    lactate levels at the end of the each 3-minute grades of each cardiopulmonary exercise tests

    just before the first ozone therapy session and immediately after the last ozone therapy session

Study Arms (1)

healthy participants

EXPERIMENTAL

healthy, physically active people will be included the study.

Other: ozone therapy

Interventions

Medical ozone is a mixture of pure ozone gas (0.05-5%) and pure oxygen (99.95-95%). It is produced from pure medical oxygen by medical ozone generators. It is applied to the participants 10 sessions by the intravenous method.

healthy participants

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • healthy
  • aged between 18-35 years old

You may not qualify if:

  • suffering from a low back or lower extremity injury or surgical operation in the last one year
  • having cardiovascular disease
  • having glucose 6 phosphate dehydrogenase enzyme deficiency
  • having chronic metabolic disease
  • having hyperthyroidism, mental and psychological problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şensu Dinçer

Istanbul, 34093, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 22, 2024

Study Start

August 12, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations