Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Change of blood pressure
Study Overview
Brief 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 .
In addition, data are collected on the immune system as well as for food and sleep quality.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change of life and Sleeping quality(3 months)
- Change of blood count, liver and nephrew values(3 months)
- Change of liver and nephrew values(3 months)
- Change of pulse(3 months)