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Completed

NCT Number: NCT06357104

Detoxification From the Lipid Tract

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.

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Key information

Conditions

COVID-19 Vaccine Adverse Reaction Behavior Behavioral Symptoms Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Residential Address

Chongqing, Chongqing Municipality, 402762, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Women during pregnancy.

Treatment and study plan

electroencephalogram biofeedback

Device

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

Other names: EB

electrical brain stimulation

Device

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

Other names: EBS

ultra-low frequency transcranial magnetic stimulation

Device

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.

Other names: ULF-TMS

sertraline hydrochloride

Drug

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

Other names: SSRI

Clonazepam

Drug

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

alprazolam

Drug

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

metoprolol

Drug

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

Other names: beta blocker

Olanzapine

Drug

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.

Pravastatin Sodium 20 MG

Drug

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

Sacubitril Valsartan Sodium Hydrate

Drug

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

Other names: ARNI

Primary outcomes

  1. Changes in Leukocyte and Components' Quantities

    Time frame: 24 days

    All white blood cells are evaluated.

  2. Changes in Leukocyte Components' Ratios

    Time frame: 24 days

    All white blood cells are evaluated.

  3. Quantity Changes in Megakaryocyte-Erythroid Progenitor

    Time frame: 24 days

  4. Changes in Hemoglobin Distribution

    Time frame: 24 days

  5. Changes in Mean Corpuscular Hemoglobin

    Time frame: 24 days

  6. Changes in Hematocrit

    Time frame: 24 days

  7. Changes in Plateletcrit

    Time frame: 24 days

  8. Red cell Distribution Width Coefficient of Variation

    Time frame: 24 days

  9. Changes in Particulate Matter Sizes

    Time frame: 24 days

  10. Changes in Total Lipid Quantities

    Time frame: 24 days

  11. Changes in Apolipoproteina

    Time frame: 24 days

  12. Changes in Lipoprotein (a)

    Time frame: 24 days

Secondary outcomes

  1. Blood Pressure Changes

    Time frame: 24 days

    Recorded systolic and diastolic blood pressures' changes before and after medication each day.

  2. Heart Rate Changes

    Time frame: 24 days

    Heart rate changes before and after medication each day.

Sponsors and collaborators

Lead sponsor

Pachankis, Yang I., M.D.

Indiv

Collaborators

  • First Affiliated Hospital of Chongqing Medical University

Registry information

Official study title

Detoxification From the Lipid Tract by Cocktail Design

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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