JMIR Publications

ABSTRACT

Background:

The Pudilan xiaoyan oral liquid(PDL)is a widely used Proprietary Chinese medicine preparation for upper respiratory tract infection(URTI), known for its significant therapeutic effects. However, The safety profiles reported in several observational studies vary, and these studies primarily focus on efficacy rather than specifically addressing safety concerns, thus not representing dedicated safety studies with low probability.

Objective:

This study aimed to investigate the incidence of adverse reactions associated with PDL and explore the factors contributing to these reactions.

Methods:

A total of 17 hospitals from China were involved in the study.The study is expected to enroll a large sample of 10,000 patients aged between 18 and 80 years with upper respiratory tract infection who were prescribed PDL.The subjects’ data including demographics,medical history,diagnostic information,medication details,adverse events,and laboratory test results were monitored.The occurrence of adverse drug reactions(ADRs) was recorded.The primary outcome is the Incidence of Adverse Drug Reaction.Secondary outcomes are The Ratio of Body Temperature to Normal and changes in liver and kidney function.Nested case-control study will be used to further analyze the influencing factors of ADR.

Results:

The study was a prospective, observational, multicenter hospital-based surveillance conducted from July 17, 2019 onwards. Due to the slow progress of the project, progress has been postponed, and the final case will be enrolled on January 31, 2025.Then,the incidence of ADR will be calculated.additionally,an in-depthanalysis will be conducted to identify the influencing factors of ADR.

Conclusions:

The study was a prospective, observational, multicenter hospital-based surveillance conducted from July 17, 2019 onwards. Due to the slow progress of the project, progress has been postponed, and the final case will be enrolled on January 31, 2025.Then,the incidence of ADR will be calculated.additionally,an in-depthanalysis will be conducted to identify the influencing factors of ADR. Clinical Trial: This research scheme has been registered internationally in“Clinicaltrial.gov” (registration number:No.NCT04031651).