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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Herrmann Apparatebau GmbH.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01902602
First Posted: July 18, 2013
Last Update Posted: August 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Herrmann Apparatebau GmbH
  Purpose

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.


Condition
Hypertonia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia

Resource links provided by NLM:


Further study details as provided by Herrmann Apparatebau GmbH:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
Blood samples

Estimated Enrollment: 100
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients which fulfill the mentioned criterias.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902602


Locations
Germany
Dr. Panos Porikis Recruiting
Biblis, Hessen, Germany, 68647
Contact: Panos Porikis, Phd    +49 6245 8698    Dr.Porikis@t-online.de   
Principal Investigator: Panos Porikis, Phd         
Sponsors and Collaborators
Herrmann Apparatebau GmbH
Investigators
Principal Investigator: Panos Porikis, Phd unafflicated
  More Information

Responsible Party: Herrmann Apparatebau GmbH
ClinicalTrials.gov Identifier: NCT01902602     History of Changes
Other Study ID Numbers: HAB10-2012
First Submitted: July 15, 2013
First Posted: July 18, 2013
Last Update Posted: August 13, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms