# Yiqi Gubiao Pill for tuberculosis-associated obstructive pulmonary disease: protocol for a double-blind randomized controlled trial

## TL;DR

This study will test the effectiveness and safety of Yiqi Gubiao Pill for treating tuberculosis-associated obstructive pulmonary disease in a clinical trial.

## Contribution

The trial introduces a novel multi-target Traditional Chinese Medicine treatment for a challenging respiratory condition.

## Key findings

- Yiqi Gubiao Pill showed preclinical benefits like cough suppression and bronchospasm relief.
- The trial will assess therapeutic efficacy and safety over a 12-week period.
- Results may provide a new treatment option for TOPD patients.

## Abstract

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.

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.

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.

[ClinicalTrials.gov], identifier [NCT06676800]. Registered 30 October 2024, https://ClinicalTrials.gov.

Flowchart showing a clinical trial process with two groups. Both groups receive Rifampicin, Isoniazid, Pyrazinamide, and Ethambutol. One group receives Yiqi Gubiao Pill, significantly alleviating symptoms and reducing recurrence. The other group receives Yiqi Gubiao Pill Placebo, achieving effective control. The process includes stages: Enrollment, Treatment, and Evaluation.