STUDY PROTOCOL article
Front. Pharmacol.
Sec. Obstetric and Pediatric Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1625547
Xiao'er Fengreqing Oral Liquid versus Xiao'er Yanbian Granules for pediatric acute pharyngitis/tonsillitis (external wind heat syndrome): Protocol and statistical analysis plan for a multi-center, randomized, double-blind, active drug-controlled trial
Provisionally accepted
- 1Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
- 2Business Analytics, University of Colorado Denver, Denver, United States
- 3The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China
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Objective: To evaluate the effectiveness and safety of Xiao'er Fengreqing Oral Liquid (XFOL) for pediatric acute pharyngitis/tonsillitis (external wind heat syndrome) through a multi-center, randomized, double-blind, positive-controlled, non-inferiority clinical trial.Method: A total of 120 participants (60 per group) will be randomized to receive either XFOL or Xiao'er Yanbian Granules (positive control) for 5 days. The primary outcome is the throat pain resolution rate and overall effective rate at Day 5, assessed via the Wong-Baker Faces Pain Rating Scale (WBS). Secondary outcomes include time to symptom onset/resolution, fever resolution time, and traditional Chinese medicine (TCM) syndrome scores. Safety assessments will monitor adverse events, vital signs, and laboratory parameters. Statistical analyses will follow a pre-specified plan, employing non-inferiority testing, survival analysis for time-to-event endpoints, and generalized estimating equations for repeated measures. Missing data will be handled using the last observation carried forward (LOCF) method for effectiveness endpoints, while safety analyses will rely on observed cases.This trial will provide rigorous evidence on the non-inferiority and safety profile of Fengreqing Oral Liquid, supporting its integration into pediatric care for acute upper respiratory infections. Adherence to a predefined statistical analysis plan ensures transparency and minimizes bias, ultimately guiding evidence-based clinical practice for TCM interventions.
Keywords: Pharyngitis, Tonsillitis, Xiao'er Fengreqing Oral Liquid, randomized controlled trial, Non-inferiority design, Trial protocol, Statistical analysis plan
Received: 09 May 2025; Accepted: 30 Jun 2025.
Copyright: © 2025 Liu, Shi, Song, Du, Yuan, Shi, Liu, Liu and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Zhaolan Liu, Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.