Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia (HAB)

March 12, 2020 updated by: Herrmann Apparatebau GmbH

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 Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Biblis, Hessen, Germany, 68647
        • Dr. Panos Porikis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients which fulfill the mentioned criterias.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months
Change of liver and nephrew values
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herrmann Apparatebau GmbH

Investigators

  • Principal Investigator: Panos Porikis, Phd, unafflicated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2013

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (ESTIMATE)

July 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAB10-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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