Observational study to evaluate the safety and performance of adjuvant ozone therapy used as intestinal insufflation for chronic diseases with special consideration of chronic infectious events.

Observational study to evaluate the safety and performance of adjuvant ozone therapy used as intestinal insufflation for chronic diseases with special consideration of chronic infectious events. - OZARIS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035930

Enrollment

Registered

2025-01-17

Start date

2025-01-23

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

U09.9

Interventions

Group 1: Group A: Main treatment plus adjuvant ozone therapy Visit -1: Patient information, informed consent Visit 0: Baseline (day 0

or up to a maximum of 7 days earlier) - Demographic data, medical history, diagnosis - EQ-5D, symptom score - Laboratory parameters - Randomization Group A only: Visit 1-10: Ozone treatment (day 1, 3

± 1 day each) - Ozone treatment Visit 10: Questionnaires (day 21

± 1 day) - EQ-5D, symptom score Visit 11: Follow-up examination (day 35

± 1 day) - EQ-5D, symptom score - Laboratory parameters Main treatment takes place from inclusion for all participants. Follow-up questions on adverse events and product deficiencies are always asked

or up to a maximum of 7 days earlier) - Demographic data, medical history, diagnosis - EQ-5D, symptom score - Laboratory parameters - Randomization Visit 10: Questionnaires (day 21

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) consent signed by the patient after informed consent 2) diagnosis: Long COVID-19, post-acute COVID-19-syndrome and post-COVID-19 syndrome (ICD-10 U09.9). 3) age over 18 years 4) ability to tolerate ozone insufflation 5) willingness to comply with the protocol and to participation in follow-up examinations The contraindications in the instructions for use must be taken into account when selecting patients and using the tester must be taken into account.

Exclusion criteria

Exclusion criteria: - Uncontrolled or acute medical conditions that require immediate intervention. - pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
Changes in quality of life, assessed using the EQ-VAS questionnaire at visit 0 and visit 11.	—

Secondary

Measure	Time frame
Secondary outcome performance: I) Changes in Bioenergetic Health Index (BHI), C-reactive protein (CRP), tumor necrosis factor (TNF)-a and D-dimers before and two weeks after ozone therapy (V0 and V11) are analyzed. II) Assessment of the EQ-5D-5L score at three time points (V0, V10 and V11) III) Assessment of the symptom score of five main symptoms at three time points (V0, V10 and V11) Secondary outcome safety: I) frequency and severity of product-related adverse events (ADEs) II) changes in the gut-associated parameters fatty acid binding protein (FABP2) and calprotectin.	—

Measure

Time frame

Secondary outcome performance: I) Changes in Bioenergetic Health Index (BHI), C-reactive protein (CRP), tumor necrosis factor (TNF)-a and D-dimers before and two weeks after ozone therapy (V0 and V11) are analyzed. II) Assessment of the EQ-5D-5L score at three time points (V0, V10 and V11) III) Assessment of the symptom score of five main symptoms at three time points (V0, V10 and V11) Secondary outcome safety: I) frequency and severity of product-related adverse events (ADEs) II) changes in the gut-associated parameters fatty acid binding protein (FABP2) and calprotectin.

—

Countries

Germany

Contacts

Public ContactJennifer Shannon

HAB® HERRMANN Apparatebau GmbH

jshannon@hab.gmbh+49 6022 6581-3

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026