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

NCT01902602 | Terminated

• 1 other identifier: HAB10-2012
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertonia

Outcome Measures

Primary Outcomes (1)

• Change of blood pressure

  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.

  3 months

Secondary Outcomes (4)

• Change of pulse

  3 months

• Change of blood count, liver and nephrew values

  3 months

• Change of liver and nephrew values

  3 months

• Change of life and Sleeping quality

  3 months

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients which fulfill the mentioned criterias.

You may qualify if:

• Resistant Hypertension \> 140 / \> 90mmHg
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herrmann Apparatebau GmbH: lead

Study Sites (1)

Dr. Panos Porikis

Biblis, Hesse, 68647, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Muscle Hypertonia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Panos Porikis, Phd

  unafflicated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 18, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

DE (1)