Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT03475732
Brief Summary:
Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis
Detailed Description:
XueBiJing injection, a five-herb combination approved by Chinese FDA in 2004, has been widely used as an add-on therapy in routine sepsis care in Chinese clinics. A comprehensive pharmacokinetic research on this herbal injection has been conducted in healthy human subjects, and the major circulating XueBiJing compounds, as well as their systemic exposure levels and forms and pharmacokinetic characteristics, have been identified. However, it is known that sepsis may induce hepatic, renal and cardiac dysfunction, alter drug metabolizing enzymes and transporters activities, increase capillary permeability, and induce various pathophysiological changes. All these will affect the concentrations at the action sites and pharmacokinetic characteristics of XueBiJing compounds, which contribute to the injection's overall therapeutic action, thus influencing the anti-septic efficacy of the injection. The purpose of this prospective, open label study is to identify the circulating XueBiJing compounds in patients with sepsis after intravenously dosing XueBiJing injection and their systemic exposure forms and levels, pharmacokinetic characteristics, and the associated inter-patient differences of these XueBiJing compounds.
Study:
NCT03475732
Study Brief:
Protocol Section:
NCT03475732