Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-03 @ 2:17 PM
Study NCT ID:
NCT01902602
Status:
TERMINATED
Last Update Posted:
2020-03-16
First Post:
2013-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009122', 'term': 'Muscle Hypertonia'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Lack of compliance of the clinical site', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2013-07-15', 'studyFirstSubmitQcDate': '2013-07-16', 'lastUpdatePostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of blood pressure', 'timeFrame': '3 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change of pulse', 'timeFrame': '3 months', 'description': 'The Pulse will be measured at each follow-up. It will be measured 3 times at the dominate arm.'}, {'measure': 'Change of blood count, liver and nephrew values', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'Change of liver and nephrew values', 'timeFrame': '3 months'}, {'measure': 'Change of life and Sleeping quality', 'timeFrame': '3 months', 'description': 'Change of life and sleeping quality will be measured in a 7 scale. This questionnaire is to fill in by the patient.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertonia']}, 'descriptionModule': {'briefSummary': '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 .\n\nIn addition, data are collected on the immune system as well as for food and sleep quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients which fulfill the mentioned criterias.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resistant Hypertension \\> 140 / \\> 90mmHg\n* Inclusion age : 45 +\n* Regular monitoring of blood levels considered\n* pre-medication to lower blood pressure for at least 3 weeks before the preliminary investigation consistent\n* Men and Women\n\nExclusion Criteria:\n\n* derailed diabetes\n* renal impairment , renal creatinine clear \\<50 ml\n* Non - austherapierte cancer / tumor patients\n* Non - adjusted thyroid dysfunction\n* BMI\\> 35\n* LVEF \\<limit ( " 35% " )\n* Peripheral AVK ( ABI - measurement ) \\> Stage II\n* regurgitation \\> Stage I\n* abdominal aneurysm\n* infections\n* acute febrile infections with temperature \\> 38.5 ° C\n* COPD and asthma to stage III\n* dyspnea NYHA \\> Stage III\n* z.n. Stroke shorter than 12 weeks\n* Acute liver failure\n* Acute Apoplexy\n* Severe poisoning\n* drug addiction\n* hyperthyroidism\n* Hypotension\n* hypocalcemia\n* hypoglycemia\n* ozone allergy\n* pregnancy\n* clotting problems ( hemophilia )\n* pre-existing condition with hemoglobin \\< 9mg/dl\n* Fresh myocardial infarction\n* Internal bleeding\n* thrombocytopenia\n* Acute alcohol\n* Citrus allergy when using sodium citrate'}, 'identificationModule': {'nctId': 'NCT01902602', 'acronym': 'HAB', 'briefTitle': 'Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Herrmann Apparatebau GmbH'}, 'officialTitle': 'Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia', 'orgStudyIdInfo': {'id': 'HAB10-2012'}}, 'contactsLocationsModule': {'locations': [{'zip': '68647', 'city': 'Biblis', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Dr. Panos Porikis', 'geoPoint': {'lat': 49.69167, 'lon': 8.45861}}], 'overallOfficials': [{'name': 'Panos Porikis, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'unafflicated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herrmann Apparatebau GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}