STUDY PROTOCOL article
Front. Pharmacol.
Sec. Pharmacology of Infectious Diseases
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1610889
This article is part of the Research TopicComplex Interplay Between Lung Diseases and Multisystem Disorders: Pathogenesis, management, and OutcomeView all 10 articles
Yiqi Gubiao Pill for Tuberculosis-Associated Obstructive Pulmonary Disease: Protocol for a Double-Blind Randomized Controlled Trial
Provisionally accepted
Jin Dai1*
Yifan Zhang2
Jun Su1Guoxiang Yuan1
Fengsen Li1Zhian Zhou1Ziza A1Chunying Ye3Aznamu Seyiti4Maihesebu Pida4
Jian Zhang1*- 1Xinjiang Medical University, Ürümqi, China
- 2Beijing University of Chinese Medicine, Beijing, Beijing Municipality, China
- 3The Second People’s Hospital of Kuqa City, xinjiang, China
- 4Shache County People's Hospital, Xinjiang, China
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Background: Tuberculosis-associated obstructive pulmonary disease (TOPD), recognized as a high-morbidity respiratory condition in most countries, presents significant clinical challenges in differential diagnosis and comorbidity management, while substantially elevating all-cause mortality risk. Preclinical investigations of Yiqi Gubiao Pill (National Patent ZL201410536529.5) have demonstrated multi-target therapeutic efficacy, including cough suppression, bronchospasm alleviation, sputum expectoration facilitation, and disease progression retardation. This randomized controlled trial aims to systematically assess Yiqi Gubiao's therapeutic and evaluate its safety. Methods: We will implement a prospective double-blind randomized controlled trial utilizing 1:1 allocation ratio, randomly assigned to either the Yiqi Gubiao pill treatment group or placebo-controlled group. Following randomization, a standardized 12-week therapeutic protocol will be administered, during which serial pulmonary function assessments and quality of life evaluations will be conducted. Concurrently, validated Traditional Chinese Medicine (TCM) symptom scoring scales will be applied for score. Systematic safety surveillance will be performed through weekly monitoring of adverse events. Discussion: This prospective, double-blind, randomized clinical trial will provide valuable data on the efficacy and safety of Yiqi Gubiao pill in treating TOPD. Positive results will offer a new treatment option for patients with TOPD. Clinical trial registration: ClinicalTrials.gov, NCT06676800. Registered 30 October 2024, https:// ClinicalTrials.gov
Keywords: Yiqi Gubiao pill, Active pulmonary tuberculosis, Tuberculosis-associated obstructive pulmonary disease, Double-blind randomized controlled trial, Traditional Chinese medicine
Received: 13 Apr 2025; Accepted: 22 Sep 2025.
Copyright: © 2025 Dai, Zhang, Su, Yuan, Li, Zhou, A, Ye, Seyiti, Pida and Zhang. 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:
Jin Dai, daijintcm@163.com
Jian Zhang, 2814714192@qq.com
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.