Trial record 6 of 171 for:    Hypertonia

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014