Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT06357104
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2024-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detoxification From the Lipid Tract
Sponsor:
Organization:
Raw JSON
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'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-07', 'size': 479591, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2024-03-15T00:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2024-03-10', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Changes in Leukocyte and Components' Quantities", 'timeFrame': '24 days', 'description': 'All white blood cells are evaluated.'}, {'measure': "Changes in Leukocyte Components' Ratios", 'timeFrame': '24 days', 'description': 'All white blood cells are evaluated.'}, {'measure': 'Quantity Changes in Megakaryocyte-Erythroid Progenitor', 'timeFrame': '24 days'}, {'measure': 'Changes in Hemoglobin Distribution', 'timeFrame': '24 days'}, {'measure': 'Changes in Mean Corpuscular Hemoglobin', 'timeFrame': '24 days'}, {'measure': 'Changes in Hematocrit', 'timeFrame': '24 days'}, {'measure': 'Changes in Plateletcrit', 'timeFrame': '24 days'}, {'measure': 'Red cell Distribution Width Coefficient of Variation', 'timeFrame': '24 days'}, {'measure': 'Changes in Particulate Matter Sizes', 'timeFrame': '24 days'}, {'measure': 'Changes in Total Lipid Quantities', 'timeFrame': '24 days'}, {'measure': 'Changes in Apolipoproteina', 'timeFrame': '24 days'}, {'measure': 'Changes in Lipoprotein (a)', 'timeFrame': '24 days'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure Changes', 'timeFrame': '24 days', 'description': "Recorded systolic and diastolic blood pressures' changes before and after medication each day."}, {'measure': 'Heart Rate Changes', 'timeFrame': '24 days', 'description': 'Heart rate changes before and after medication each day.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sebaceous immunobiology', 'lipid', 'depression'], 'conditions': ['COVID-19 Vaccine Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '31207206', 'type': 'BACKGROUND', 'citation': 'Kim H, Nobeyama T, Honda S, Yasuda K, Morone N, Murakami T. Membrane fusogenic high-density lipoprotein nanoparticles. Biochim Biophys Acta Biomembr. 2019 Oct 1;1861(10):183008. doi: 10.1016/j.bbamem.2019.06.007. Epub 2019 Jun 15.'}, {'pmid': '34124081', 'type': 'BACKGROUND', 'citation': 'Zhao M, Luo Z, He H, Shen B, Liang J, Zhang J, Ye J, Xu Y, Wang Z, Ye D, Wang M, Wan J. Decreased Low-Density Lipoprotein Cholesterol Level Indicates Poor Prognosis of Severe and Critical COVID-19 Patients: A Retrospective, Single-Center Study. Front Med (Lausanne). 2021 May 26;8:585851. doi: 10.3389/fmed.2021.585851. eCollection 2021.'}, {'pmid': '32428379', 'type': 'BACKGROUND', 'citation': 'Glebov OO. Understanding SARS-CoV-2 endocytosis for COVID-19 drug repurposing. FEBS J. 2020 Sep;287(17):3664-3671. doi: 10.1111/febs.15369. Epub 2020 Jun 2.'}, {'type': 'BACKGROUND', 'citation': 'Pachankis YI. Plausibility Review on Lipoprotein (A) Infection Path of S2 Autoimmune Pathogen. Global Journal of Medical Research. 2023;23(3)(C):5-11.'}, {'pmid': '24733016', 'type': 'BACKGROUND', 'citation': 'Yang Y, Lian YT, Huang SY, Yang Y, Cheng LX, Liu K. GABA and topiramate inhibit the formation of human macrophage-derived foam cells by modulating cholesterol-metabolism-associated molecules. Cell Physiol Biochem. 2014;33(4):1117-29. doi: 10.1159/000358681. Epub 2014 Apr 9.'}, {'pmid': '32364672', 'type': 'BACKGROUND', 'citation': 'Lombardi JP, Kinzlmaier DA, Jacob TC. Visualizing GABA A Receptor Trafficking Dynamics with Fluorogenic Protein Labeling. Curr Protoc Neurosci. 2020 Jun;92(1):e97. doi: 10.1002/cpns.97.'}, {'pmid': '23789008', 'type': 'BACKGROUND', 'citation': 'Griffin CE 3rd, Kaye AM, Bueno FR, Kaye AD. Benzodiazepine pharmacology and central nervous system-mediated effects. Ochsner J. 2013 Summer;13(2):214-23.'}, {'pmid': '21499463', 'type': 'BACKGROUND', 'citation': 'Al-Tubuly R, Aburawi S, Alghzewi E, Gorash Z, Errwami S. The effect of sympathetic antagonists on the antidepressant action of alprazolam. Libyan J Med. 2008 Jun 1;3(2):78-83. doi: 10.4176/080101.'}, {'pmid': '6118165', 'type': 'BACKGROUND', 'citation': 'Hunninghake D, Wallace RB, Reiland S, Barrett-Connor E, Wahl P, Hoover J, Heiss G. Alterations of plasma lipid and lipoprotein levels associated with benzodiazepine use--the LRC Program Prevalence Study. Atherosclerosis. 1981 Oct;40(2):159-65. doi: 10.1016/0021-9150(81)90034-4.'}, {'pmid': '34386973', 'type': 'BACKGROUND', 'citation': 'McGrath M, Hoyt H, Pence A, Forman SA, Raines DE. Selective actions of benzodiazepines at the transmembrane anaesthetic binding sites of the GABAA receptor: In vitro and in vivo studies. Br J Pharmacol. 2021 Dec;178(24):4842-4858. doi: 10.1111/bph.15662. Epub 2021 Sep 26.'}, {'pmid': '35916248', 'type': 'BACKGROUND', 'citation': 'Mascarenhas FNADP, Silva NF, Menezes-Reis LT, Vieira LG, Hirano LQL, Botelho FV, Ribeiro DL, Zanon RG. Prenatal effects of alprazolam treatment on the immature cerebellum of rats. Int J Dev Neurosci. 2022 Dec;82(8):727-735. doi: 10.1002/jdn.10222. Epub 2022 Aug 5.'}, {'pmid': '29767950', 'type': 'BACKGROUND', 'citation': 'Elgarf AA, Siebert DCB, Steudle F, Draxler A, Li G, Huang S, Cook JM, Ernst M, Scholze P. Different Benzodiazepines Bind with Distinct Binding Modes to GABAA Receptors. ACS Chem Biol. 2018 Aug 17;13(8):2033-2039. doi: 10.1021/acschembio.8b00144. Epub 2018 Jul 23.'}, {'type': 'BACKGROUND', 'citation': 'Pachankis YI. Adrenaline Intolerance in ASD Curing From Autoimmune Pathogens - Sebaceous Immunobiology in Autoimmune Pathogen Research. Biomedical Review: Journal of Basic and Applied Medical Sciences. 2023;10(1):8-14.'}, {'pmid': '19641187', 'type': 'BACKGROUND', 'citation': 'Kottyan LC, Collier AR, Cao KH, Niese KA, Hedgebeth M, Radu CG, Witte ON, Khurana Hershey GK, Rothenberg ME, Zimmermann N. Eosinophil viability is increased by acidic pH in a cAMP- and GPR65-dependent manner. Blood. 2009 Sep 24;114(13):2774-82. doi: 10.1182/blood-2009-05-220681. Epub 2009 Jul 29.'}, {'pmid': '38626245', 'type': 'BACKGROUND', 'citation': 'Petersen OH, Gerasimenko OV, Gerasimenko JV. Endocytic uptake of SARS-CoV-2: the critical roles of pH, Ca2+, and NAADP. Function (Oxf). 2020 Jun 5;1(1):zqaa003. doi: 10.1093/function/zqaa003. eCollection 2020. No abstract available.'}, {'pmid': '36081497', 'type': 'BACKGROUND', 'citation': 'Cao Z, Zhao M, Sun H, Hu L, Chen Y, Fan Z. Roles of mitochondria in neutrophils. Front Immunol. 2022 Aug 19;13:934444. doi: 10.3389/fimmu.2022.934444. eCollection 2022.'}, {'pmid': '20375550', 'type': 'BACKGROUND', 'citation': 'Fox S, Leitch AE, Duffin R, Haslett C, Rossi AG. Neutrophil apoptosis: relevance to the innate immune response and inflammatory disease. J Innate Immun. 2010;2(3):216-27. doi: 10.1159/000284367. Epub 2010 Feb 11.'}, {'pmid': '20375558', 'type': 'BACKGROUND', 'citation': 'Parihar A, Eubank TD, Doseff AI. Monocytes and macrophages regulate immunity through dynamic networks of survival and cell death. J Innate Immun. 2010;2(3):204-15. doi: 10.1159/000296507. Epub 2010 Mar 16.'}, {'pmid': '34777794', 'type': 'BACKGROUND', 'citation': 'Salih RQ, Salih GA, Abdulla BA, Ahmed AD, Mohammed HR, Kakamad FH, Salih AM. False-positive HIV in a patient with SARS-CoV-2 infection; a case report. Ann Med Surg (Lond). 2021 Nov;71:103027. doi: 10.1016/j.amsu.2021.103027. Epub 2021 Nov 6.'}, {'pmid': '32642434', 'type': 'BACKGROUND', 'citation': 'Robinson MA, Nagurla SR, Noblitt TR, Almaghlouth NK, Al-Rahamneh MM, Cashin LM. Falsely positive fourth generation ADVIA Centaur(R) HIV Antigen/Antibody Combo assay in the presence of autoimmune hepatitis type I (AIH). IDCases. 2020 Jun 25;21:e00886. doi: 10.1016/j.idcr.2020.e00886. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'https://www.emcdda.europa.eu/publications/drug-profiles/benzodiazepines_en', 'label': 'Benzodiazepines drug profile. European Monitoring Centre for Drugs and Drug Addiction.'}, {'url': 'http://www.scientificamerican.com/article/antianxiety-drugs-successfully-treat-autism/', 'label': 'Antianxiety Drugs Successfully Treat Autism'}]}, 'descriptionModule': {'briefSummary': 'Apart from electroencephalogram biofeedback and electrical brain stimulation adopted for maintenance treatment, the study utilizes ultra-low frequency transcranial magnetic stimulation (ULF-TMS) for initial γ-aminobutyric acid (GABA) stimulation. The cocktail therapy starts after the primary efficacy endpoint, and concomitant therapy is adopted throughout the study.', 'detailedDescription': 'It was tested that GABA, in the joint action with topiramate, modulates macrophage activities by modulating cholesterol-metabolism associated molecules. GABA A receptors exhibit highly dynamic trafficking and cell surface mobility and influence on post-endocytic effects. Benzodiazepines (BZDs) exercise the mechanism of action by facilitating the binding of the inhibitory neurotransmitter GABA at various GABA receptors throughout the central nervous system (CNS). Alprazolam, a type of BZD, was tested by Al-Tubuly, Aburawi, Alghzewi, Gorash and Errwami in joint action with water-soluble beta blocker atenolol, in comparison with the non-selective β-adrenoceptor antagonist propranolol on the pharmacological effects on depression. The study hypothesizes that by replacing the water-soluble beta blocker to lipid-soluble one metoprolol, the effect of detoxification from the lipid and sebaceous immunobiological pathways can be achieved by the clathrin-dependent endocytosis process.\n\nEven though partial progress was made in the NCT05839236 trial by statin therapies, the therapeutic effects have not been lasting nor significant. The study develops from the previous protocol for a cocktail therapy by the joint mechanism of actions of alprazolam, metoprolol, and pravastatin sodium for the detoxification process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People who received full doses of COVID-19 vaccines.\n\nExclusion Criteria:\n\n* Women during pregnancy.'}, 'identificationModule': {'nctId': 'NCT06357104', 'briefTitle': 'Detoxification From the Lipid Tract', 'organization': {'class': 'INDIV', 'fullName': 'Pachankis, Yang I., M.D.'}, 'officialTitle': 'Detoxification From the Lipid Tract by Cocktail Design', 'orgStudyIdInfo': {'id': 'SCI-CT-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GABA Cocktail', 'interventionNames': ['Device: electroencephalogram biofeedback', 'Device: electrical brain stimulation', 'Device: ultra-low frequency transcranial magnetic stimulation', 'Drug: Sertraline Hydrochloride', 'Drug: Clonazepam', 'Drug: Alprazolam', 'Drug: Metoprolol', 'Drug: Olanzapine', 'Drug: Pravastatin Sodium 20 MG', 'Drug: Sacubitril Valsartan Sodium Hydrate']}], 'interventions': [{'name': 'electroencephalogram biofeedback', 'type': 'DEVICE', 'otherNames': ['EB'], 'description': 'EB is conducted for 20 minutes per section with two sections per day in the primary efficacy endpoint.', 'armGroupLabels': ['GABA Cocktail']}, {'name': 'electrical brain stimulation', 'type': 'DEVICE', 'otherNames': ['EBS'], 'description': 'EBS is conducted for 20 minutes per section per day in the primary efficacy endpoint.', 'armGroupLabels': ['GABA Cocktail']}, {'name': 'ultra-low frequency transcranial magnetic stimulation', 'type': 'DEVICE', 'otherNames': ['ULF-TMS'], 'description': "ULF-TMS is conducted mainly for the left side of the participant's brain for 20 minutes per section per day in the primary efficacy endpoint.", 'armGroupLabels': ['GABA Cocktail']}, {'name': 'Sertraline Hydrochloride', 'type': 'DRUG', 'otherNames': ['SSRI'], 'description': 'Sertraline is taken in the morning for 150 mg per day.', 'armGroupLabels': ['GABA Cocktail']}, {'name': 'Clonazepam', 'type': 'DRUG', 'description': 'Clonazepam is taken in the morning for 1 mg per day.', 'armGroupLabels': ['GABA Cocktail']}, {'name': 'Alprazolam', 'type': 'DRUG', 'description': 'Alprazolam is introduced near the end of the primary efficacy endpoint for 0.4 mg per night.', 'armGroupLabels': ['GABA Cocktail']}, {'name': 'Metoprolol', 'type': 'DRUG', 'otherNames': ['beta blocker'], 'description': 'Metoprolol is introduced at the secondary efficacy endpoint starting with 47.5 mg per night and increase to 95 mg per night.', 'armGroupLabels': ['GABA Cocktail']}, {'name': 'Olanzapine', 'type': 'DRUG', 'description': 'Olanzapine is taken throughout the trial with 7.5 mg per night at first, and increases to 10 mg per night after the cocktail therapy.', 'armGroupLabels': ['GABA Cocktail']}, {'name': 'Pravastatin Sodium 20 MG', 'type': 'DRUG', 'description': 'Pravastatin sodium is introduced in the secondary efficacy endpoint with 20 mg per night.', 'armGroupLabels': ['GABA Cocktail']}, {'name': 'Sacubitril Valsartan Sodium Hydrate', 'type': 'DRUG', 'otherNames': ['ARNI'], 'description': 'Sacubitril valsartan sodium is introduced in the secondary efficacy endpoint with 100 mg per day.', 'armGroupLabels': ['GABA Cocktail']}]}, 'contactsLocationsModule': {'locations': [{'zip': '402762', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Residential Address', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES', 'description': 'IPD will be shared on Zenodo repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pachankis, Yang I., M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-04-11', 'type': 'RELEASE'}, {'date': '2024-09-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Pachankis, Yang I., M.D.'}}}}