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

Hypertonia Clinical Trial

— HAB  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01902602
• Other study ID #: HAB10-2012
• Status: Terminated
• Start date: August 2013
• Est. completion date: June 2016

Study information

• Verified date: March 2020
• Source: Herrmann Apparatebau GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 .

In addition, data are collected on the immune system as well as for food and sleep quality.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertonia
• Muscle Hypertonia

Locations

Country	Name	City	State
Germany	Dr. Panos Porikis	Biblis	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Herrmann Apparatebau GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of pulse	The Pulse will be measured at each follow-up. It will be measured 3 times at the dominate arm.	3 months
Secondary	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
Secondary	Change of liver and nephrew values		3 months
Secondary	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