NCT06357104

Detoxification From the Lipid Tract

Detoxification From the Lipid Tract by Cocktail Design

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Pachankis, Yang I., M.D. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19 Vaccine Adverse Reaction

Interventions

Type	Name	Description
DEVICE	electroencephalogram biofeedback	EB is conducted for 20 minutes per section with two sections per day in the primary efficacy endpoint.
DEVICE	electrical brain stimulation	EBS is conducted for 20 minutes per section per day in the primary efficacy endpoint.
DEVICE	ultra-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.
DRUG	Sertraline Hydrochloride	Sertraline is taken in the morning for 150 mg per day.
DRUG	Clonazepam	Clonazepam is taken in the morning for 1 mg per day.
DRUG	Alprazolam	Alprazolam is introduced near the end of the primary efficacy endpoint for 0.4 mg per night.
DRUG	Metoprolol	Metoprolol is introduced at the secondary efficacy endpoint starting with 47.5 mg per night and increase to 95 mg per night.
DRUG	Olanzapine	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.
DRUG	Pravastatin Sodium 20 MG	Pravastatin sodium is introduced in the secondary efficacy endpoint with 20 mg per night.
DRUG	Sacubitril Valsartan Sodium Hydrate	Sacubitril valsartan sodium is introduced in the secondary efficacy endpoint with 100 mg per day.

Timeline

• Start date: 2024-02-26
• Primary completion: 2024-03-14
• Completion: 2024-03-20
• First posted: 2024-04-10
• Last updated: 2024-04-10

Locations

1 site across 1 country: China