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

Terminated

• Conditions: Hypertonia

• Registration Number: NCT01902602
• Lead Sponsor: Herrmann Apparatebau GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-18
• Study Start: 2013-08
• Primary Completion: 2016-03
• Study Completion: 2016-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of blood pressure	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 Outcome Measures

Name	Time	Method
Change of life and Sleeping quality	3 months	Change of life and sleeping quality will be measured in a 7 scale. This questionnaire is to fill in by the patient.
Change of blood count, liver and nephrew values	3 months	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.
Change of liver and nephrew values	3 months
Change of pulse	3 months	The Pulse will be measured at each follow-up. It will be measured 3 times at the dominate arm.

Trial Locations

Locations (1)

Dr. Panos Porikis; 🇩🇪 Biblis, Hessen, Germany