Clinical Trial: Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

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

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 Summary:
Sponsor: Herrmann Apparatebau GmbH

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change of pulse [ Time Frame: 3 months ]
    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 ]
    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 ]
  • Change of life and Sleeping quality [ Time Frame: 3 months ]
    Change of life and sleeping quality will be measured in a 7 scale. This questionnaire is to fill in by the patient.


Original Secondary Outcome: Same as current

Information By: Herrmann Apparatebau GmbH

Dates:
Date Received: July 15, 2013
Date Started: August 2013
Date Completion: June 2014
Last Updated: August 12, 2013
Last Verified: August 2013