ArticleFrontiers in pharmacology2025
Yiqi Gubiao Pill for tuberculosis-associated obstructive pulmonary disease: protocol for a double-blind randomized controlled trial.
Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06676800 (Observation Study on the Efficacy of Yiqi Gubiao Pill in the Treatment of Chronic Obstructive Pulmonary Disease Secondary to Active Pulmonary Tuberculosis), which is not on this map. Not yet cited in PubMed.
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Observation Study on the Efficacy of Yiqi Gubiao Pill in the Treatment of Chronic Obstructive Pulmonary Disease Secondary to Active Pulmonary Tuberculosis: A Double-Blind Randomized Controlled Trial Protocol
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11 authors.
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Abstract
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], identifier [NCT06676800]. Registered 30 October 2024, https://ClinicalTrials.gov.
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