Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia

NCT ID: NCT01902602

Last Updated: 2020-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Herrmann Apparatebau GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Panos Porikis, Phd

Role: PRINCIPAL_INVESTIGATOR

unafflicated

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr. Panos Porikis

Biblis, Hesse, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HAB10-2012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Telemonitoring in Arterial Hypertension
NCT07049289 ACTIVE_NOT_RECRUITING NA