Trial record 6 of 191 for:    Hypertonia

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

This study is not yet open for participant recruitment.
Verified August 2013 by Herrmann Apparatebau GmbH
Sponsor:
Information provided by (Responsible Party):
Herrmann Apparatebau GmbH
ClinicalTrials.gov Identifier:
NCT01902602
First received: July 15, 2013
Last updated: August 12, 2013
Last verified: August 2013
  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 ] [ 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.


Secondary Outcome Measures:
  • 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

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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Herrmann Apparatebau GmbH
ClinicalTrials.gov Identifier: NCT01902602     History of Changes
Other Study ID Numbers: HAB10-2012
Study First Received: July 15, 2013
Last Updated: August 12, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on April 16, 2014