Detoxification From the Lipid Tract

April 3, 2024 updated by: Pachankis, Yang I., M.D.

Detoxification From the Lipid Tract by Cocktail Design

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 402762
        • Residential Address

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Women during pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GABA Cocktail
Device: electroencephalogram biofeedback
EB is conducted for 20 minutes per section with two sections per day in the primary efficacy endpoint.
Other Names:
  • EB
Device: electrical brain stimulation
EBS is conducted for 20 minutes per section per day in the primary efficacy endpoint.
Other Names:
  • EBS
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.
Other Names:
  • ULF-TMS
Drug: Sertraline Hydrochloride
Sertraline is taken in the morning for 150 mg per day.
Other Names:
  • SSRI
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.
Other Names:
  • beta blocker
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.
Other Names:
  • ARNI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Leukocyte and Components' Quantities
Time Frame: 24 days
All white blood cells are evaluated.
24 days
Changes in Leukocyte Components' Ratios
Time Frame: 24 days
All white blood cells are evaluated.
24 days
Quantity Changes in Megakaryocyte-Erythroid Progenitor
Time Frame: 24 days
24 days
Changes in Hemoglobin Distribution
Time Frame: 24 days
24 days
Changes in Mean Corpuscular Hemoglobin
Time Frame: 24 days
24 days
Changes in Hematocrit
Time Frame: 24 days
24 days
Changes in Plateletcrit
Time Frame: 24 days
24 days
Red cell Distribution Width Coefficient of Variation
Time Frame: 24 days
24 days
Changes in Particulate Matter Sizes
Time Frame: 24 days
24 days
Changes in Total Lipid Quantities
Time Frame: 24 days
24 days
Changes in Apolipoproteina
Time Frame: 24 days
24 days
Changes in Lipoprotein (a)
Time Frame: 24 days
24 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure Changes
Time Frame: 24 days
Recorded systolic and diastolic blood pressures' changes before and after medication each day.
24 days
Heart Rate Changes
Time Frame: 24 days
Heart rate changes before and after medication each day.
24 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pachankis, Yang I., M.D.

Collaborators

First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2024

Primary Completion (Actual)

March 14, 2024

Study Completion (Actual)

March 20, 2024

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-CT-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared on Zenodo repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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