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Detoxification From the Lipid Tract

Detoxification From the Lipid Tract by Cocktail Design

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06357104
Enrollment
1
Registered
2024-04-10
Start date
2024-02-26
Completion date
2024-03-20
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Vaccine Adverse Reaction

Keywords

sebaceous immunobiology, lipid, depression

Brief summary

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.

Detailed description

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. Even 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.

Interventions

DRUGMetoprolol

Metoprolol is introduced at the secondary efficacy endpoint starting with 47.5 mg per night and increase to 95 mg per night.

DRUGOlanzapine

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.

DEVICEelectroencephalogram biofeedback

EB is conducted for 20 minutes per section with two sections per day in the primary efficacy endpoint.

EBS is conducted for 20 minutes per section per day in the primary efficacy endpoint.

DEVICEultra-low frequency transcranial magnetic stimulation

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.

Sertraline is taken in the morning for 150 mg per day.

DRUGClonazepam

Clonazepam is taken in the morning for 1 mg per day.

DRUGAlprazolam

Alprazolam is introduced near the end of the primary efficacy endpoint for 0.4 mg per night.

DRUGPravastatin Sodium 20 MG

Pravastatin sodium is introduced in the secondary efficacy endpoint with 20 mg per night.

Sacubitril valsartan sodium is introduced in the secondary efficacy endpoint with 100 mg per day.

Sponsors

First Affiliated Hospital of Chongqing Medical University
CollaboratorOTHER
Pachankis, Yang I., M.D.
Lead SponsorINDIV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* People who received full doses of COVID-19 vaccines.

Exclusion criteria

* Women during pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
Changes in Lipoprotein (a)24 days
Changes in Total Lipid Quantities24 days
Changes in Apolipoproteina24 days
Changes in Leukocyte and Components' Quantities24 daysAll white blood cells are evaluated.
Changes in Leukocyte Components' Ratios24 daysAll white blood cells are evaluated.
Quantity Changes in Megakaryocyte-Erythroid Progenitor24 days
Changes in Hemoglobin Distribution24 days
Changes in Mean Corpuscular Hemoglobin24 days
Changes in Hematocrit24 days
Changes in Plateletcrit24 days
Red cell Distribution Width Coefficient of Variation24 days
Changes in Particulate Matter Sizes24 days

Secondary

MeasureTime frameDescription
Heart Rate Changes24 daysHeart rate changes before and after medication each day.
Blood Pressure Changes24 daysRecorded systolic and diastolic blood pressures' changes before and after medication each day.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026