HypertoniaHABNCT01902602
Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia
An observational study of Hypertonia, run by Herrmann Apparatebau GmbH at 1 site in Germany.
Trial summary
The objective of this clinical study is to evaluate the influence of the Great autohemotherapy with oxygen-ozone (hyperbaric ozone therapy ) to describe the cardiovascular system in patients with resistant hypertension. The primary endpoint is the change in mean blood pressure after 10 treatments . Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hypertonia
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients which fulfill the mentioned criterias.
Who may be able to join
- Resistant Hypertension > 140 / > 90mmHg
- Regular monitoring of blood levels considered
- pre-medication to lower blood pressure for at least 3 weeks before the preliminary investigation consistent
- Men and Women
Who cannot join
- derailed diabetes
- renal impairment , renal creatinine clear <50 ml
- Non - austherapierte cancer / tumor patients
- Non - adjusted thyroid dysfunction
- BMI> 35
- LVEF <limit ( " 35% " )
Show all 31Show fewer
- Peripheral AVK ( ABI - measurement ) > Stage II
- regurgitation > Stage I
- abdominal aneurysm
- infections
- acute febrile infections with temperature > 38.5 ° C
- COPD and asthma to stage III
- dyspnea NYHA > Stage III
- z.n. Stroke shorter than 12 weeks
- Acute liver failure
- Acute Apoplexy
- Severe poisoning
- drug addiction
- hyperthyroidism
- Hypotension
- hypocalcemia
- hypoglycemia
- ozone allergy
- pregnancy
- clotting problems ( hemophilia )
- pre-existing condition with hemoglobin < 9mg/dl
- Fresh myocardial infarction
- Internal bleeding
- thrombocytopenia
- Acute alcohol
- Citrus allergy when using sodium citrate
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this clinical study is to evaluate the influence of the Great autohemotherapy with oxygen-ozone (hyperbaric ozone therapy ) to describe the cardiovascular system in patients with resistant hypertension. The primary endpoint is the change in mean blood pressure after 10 treatments .
In addition, data are collected on the immune system as well as for food and sleep quality.
- Conditions
- Hypertonia
- Medical subject headings
- Muscle Hypertonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of blood pressure
Primary endpoint is, that there is a changing of the middle blood pressure after 10 treatments. The blood pressure will get messured at all patients which get treated with oxygen-ozone. The aim is reached, if there is a reduction of the middle blood pressure after 10 treatments by 10 mmHg compared to the blood pressure by the patients at the baseline at beginning.
Measured: 3 months
Secondary outcomes (4)
Change of pulse
The Pulse will be measured at each follow-up. It will be measured 3 times at the dominate arm.
Measured: 3 months
Change of blood count, liver and nephrew values
The change of blood counts, liver and nephrew values serves as a sign for change of immune activity in a patient. Furthermore potential negative effects will be reportet as an adverse event.
Measured: 3 months
Change of liver and nephrew values
Measured: 3 months
Change of life and Sleeping quality
Change of life and sleeping quality will be measured in a 7 scale. This questionnaire is to fill in by the patient.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionJun 2016
Why it stopped: Lack of compliance of the clinical site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herrmann Apparatebau GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Panos Porikis, Phd, Principal investigator, unafflicated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902602
- Sponsor's protocol ID
- HAB10-2012
- Acronym
- HAB
- Status last verified
- Mar 2020
- First submitted
- 15 Jul 2013
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia
- ClinicalTrials.gov ID
- NCT01902602
- Acronym / sponsor ID
- HAB / HAB10-2012
- Conditions
- Hypertonia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of compliance of the clinical site
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Herrmann Apparatebau GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to evaluate the influence of the Great autohemotherapy with oxygen-ozone (hyperbaric ozone therapy ) to describe the cardiovascular system in patients with resistant hypertension. The primary endpoint is the change in mean blood pressure after 10 treatments .
In addition, data are collected on the immune system as well as for food and sleep quality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients which fulfill the mentioned criterias.
Key inclusion criteria (4 listed)
- Resistant Hypertension > 140 / > 90mmHg
- Regular monitoring of blood levels considered
- pre-medication to lower blood pressure for at least 3 weeks before the preliminary investigation consistent
- Men and Women
Key exclusion criteria (31 listed)
- derailed diabetes
- renal impairment , renal creatinine clear <50 ml
- Non - austherapierte cancer / tumor patients
- Non - adjusted thyroid dysfunction
- BMI> 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of blood pressure
Time frame: 3 months
Primary endpoint is, that there is a changing of the middle blood pressure after 10 treatments. The blood pressure will get messured at all patients which get treated with oxygen-ozone. The aim is reached, if there is a reduction of the middle blood pressure after 10 treatments by 10 mmHg compared to the blood pressure by the patients at the baseline at beginning.
4 secondary outcomes
Change of pulse
Time frame: 3 months
Change of blood count, liver and nephrew values
Time frame: 3 months
Change of liver and nephrew values
Time frame: 3 months
Change of life and Sleeping quality
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Lack of compliance of the clinical site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panos Porikis, Phd principal investigator
unafflicated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertonia, run by Herrmann Apparatebau GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of compliance of the clinical site). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of blood pressure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.