Clinical trial NCT06357104: Detoxification From the Lipid Tract
Official title: Detoxification From the Lipid Tract by Cocktail Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19 Vaccine Adverse Reaction
Keywords: sebaceous immunobiology
lipid
depression
Lead sponsor: Pachankis, Yang I., M.D.
Sponsor class: INDIV
Collaborators: name: First Affiliated Hospital of Chongqing Medical University
First posted: 2024-04-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Women during pregnancy.

Primary outcomes:
measure: Changes in Leukocyte and Components' Quantities
timeFrame: 24 days
measure: Changes in Leukocyte Components' Ratios
timeFrame: 24 days
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
Secondary outcomes:
measure: Blood Pressure Changes
timeFrame: 24 days
measure: Heart Rate Changes
timeFrame: 24 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Residential Address
state: Chongqing
Study officials:
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