Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia (HAB)
Recruitment status was: Not yet recruiting
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
|Official Title:||Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia|
- Change of blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Change of pulse [ Time Frame: 3 months ] [ Designated as safety issue: No ]The Pulse will be measured at each follow-up. It will be measured 3 times at the dominate arm.
- Change of blood count, liver and nephrew values [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Change of life and Sleeping quality [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change of life and sleeping quality will be measured in a 7 scale. This questionnaire is to fill in by the patient.
Biospecimen Retention: Samples With DNA
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01902602
|Dr. Panos Porikis|
|Biblis, Hessen, Germany, 68647|
|Principal Investigator:||Panos Porikis, Phd||unafflicated|