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
Information provided by (Responsible Party):
Herrmann Apparatebau GmbH
First received: July 15, 2013
Last updated: August 12, 2013
Last verified: August 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia
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.
Biospecimen Retention: Samples With DNA
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||45 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
All patients which fulfill the mentioned criterias.
- 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
- 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
- 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
- ozone allergy
- clotting problems ( hemophilia )
- pre-existing condition with hemoglobin < 9mg/dl
- Fresh myocardial infarction
- Internal bleeding
- Acute alcohol
- Citrus allergy when using sodium citrate
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
|Dr. Panos Porikis
|Biblis, Hessen, Germany, 68647 |
|Contact: Panos Porikis, Phd +49 6245 8698 Dr.Porikis@t-online.de |
|Principal Investigator: Panos Porikis, Phd |
Herrmann Apparatebau GmbH
||Panos Porikis, Phd
||Herrmann Apparatebau GmbH
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 15, 2013
||August 12, 2013
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 19, 2017
Nervous System Diseases
Signs and Symptoms