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

NCT05154942 | Unknown DMC

• 1 other identifier: 20211129
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Doxofylline; Acupuncture and drug combined technology; Vmax detection

Outcome Measures

Primary Outcomes (1)

• The concentration of DOXO and metabolites

  The concentrations of DOXO and its metabolites TA, TAA and ETO in blood were detected by LC-MS

  Within ten minutes after the start of administration

Study Arms (2)

DOXO+electroacupuncture

EXPERIMENTAL

EA is given every day for the first three days before DOXO pumping, and EA is given when DOXO is pumped for 30 minutes each time

Device: DOXO+electroacupuncture

Non-electroacupuncture

NO INTERVENTION

Compared to the experimental group without EA treatment

Interventions

DOXO+electroacupuncture DEVICE

DOXO+electroacupuncture

DOXO+electroacupuncture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with pneumothorax or three and three lower rib fractures.
• Age ≥18 years old and ≤40 years old, no gender limit;
• No chronic underlying disease, no new onset or acute disease;
• No long-term drug use history;
• Understand and agree to participate in this study and sign an informed consent form.

You may not qualify if:

• Patients who have received EA treatment in the past;
• Patients with skin infections in the local meridian points;
• Patients with upper or lower limb nerve injury;
• Those who have consumed tea, coffee, chocolate and smoked one week before the start of the test;
• Those suffering from respiratory diseases, hyperthyroidism, sinus tachycardia, and arrhythmia;
• Patients with severe heart, lung, liver, and kidney function abnormalities, patients with hypertension, patients with active gastric and duodenal ulcers or patients with co-infection;
• Those who have participated in or are participating in other clinical trials one month before enrollment.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead
• Shanghai University of Traditional Chinese Medicine: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 13, 2021
• Study Start: December 15, 2021
• Primary Completion: September 15, 2023
• Study Completion: November 15, 2023
• Last Updated: December 13, 2021

Record last verified: 2021-11