Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia

Study Overview
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Brief Summary
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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.

Official Title
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Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia

Conditions
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Hypertonia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resistant Hypertension > 140 / > 90mmHg Inclusion age : 45 + 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 Exclusion Criteria: derailed diabetes renal impairment , renal creatinine clear <50 ml Non - austherapierte cancer / tumor patients Non - adjusted thyroid dysfunction BMI> 35 LVEF <limit (  35%  ) 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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pulse | The Pulse will be measured at each follow-up. It will be measured 3 times at the dominate arm. | 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. | 3 months | 
| Change of liver and nephrew values |  | 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. | 3 months |