MedTrace Logo

Vmax Detection of Acupuncture-doxofylline as a Whole Probe of CYP1A in Vivo

NCT05154942 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-12-13

No results posted yet for this study

Summary

Preliminary studies have shown that before giving combined acupuncture and medicine anesthesia, electroacupuncture (EA) needs to be started three days before in order to produce a sequential effect. In combined acupuncture and drug anesthesia, the core goal is to use acupuncture to reduce the insufficiency of anesthetics in terms of analgesia, sedation, stable circulation, and protection of organs. However, the mechanism of action behind this combination has not yet been changed. The pharmacodynamics or pharmacokinetics has been convincingly explained, or the degree of recognition is not high, such as whether acupuncture has a specific target in the body, if there is a specific target, where the effect target is located ? Will it affect the metabolic enzymes and will it further affect the efficacy or toxicity of the drugs metabolized by the metabolic enzymes? What effect will it have on the pharmacokinetic mechanism? Given that it may involve complex pharmacodynamics and pharmacokinetic mechanisms, this study will first use doxofylline (DOXO) as a probe to study and explain its effect on metabolic enzymes to further clarify whether it will produce therapeutic drugs Influence.

Doxofylline (DOXO), as an old drug that has been used for many years, has extremely high safety and strong selectivity. It is a clinical drug with an injectable dosage form. Studies have proved that DOXO can be used as a high-quality P450 mixed-function oxidase CYP1A in vivo probe. DOXO is a metabolic clearance-leading drug in the human body, and it must undergo the initiation metabolism of CYP1A in the cell to be transformed into theophylline acetaldehyde ( TA), and then theophylline acetic acid (TAA) and hydroxyethyl theophylline (ETO) produced by disproportionation. Therefore, quantitative detection of TAA and ETO can calculate the maximum activity of CYP1A.

In order to study the kinetics of DOXO and reduce the inconvenience of excessive blood sampling points for long-term continuous administration, we will explore the method of detecting DOXO kinetics by the Vmax method through clinical research to characterize whether acupuncture affects the metabolic enzyme CYP1A

Conditions

  • Acupuncture
  • Drug Interaction

Interventions

DEVICE

DOXO+electroacupuncture

DOXO+electroacupuncture

Sponsors & Collaborators

  • Shanghai University of Traditional Chinese Medicine

    collaborator OTHER

  • Shanghai Yueyang Integrated Medicine Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2023-09-15
Completion
2023-11-15

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154942 on ClinicalTrials.gov