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Not yet recruiting NCT06676800

Observation Study on the Efficacy of Yiqi Gubiao Pill in the Treatment of Chronic Obstructive Pulmonary Disease Secondary to Active Pulmonary Tuberculosis

Early Phase I Interventional Tuberculosis-related Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Yiqi Gubiao pill, Yiqi Gubiao Pill placebo.
Who it may be relevant to
Registry conditions: Tuberculosis-related Obstructive Pulmonary Disease. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

Tuberculosis-related obstructive pulmonary disease (TOPD), as a high-burden disease in most countries, poses difficulties in the diagnosis and treatment of the disease when coexisting, and increases the risk of death for patients. Preliminary studies have shown that Yiqi Gubiao Wan has significant effects in relieving cough, alleviating asthma, expectorating phlegm, and delaying airway obstruction. The purpose of this study is to verify the therapeutic effect of Yiqi Gubiao pill on patients with TOPD through rigorous methodological design and to evaluate its safety. We will conduct a prospective, double-blind, randomized controlled trial. First, participants will be randomly assigned 1:1 to the Yiqi Gubiao pill treatment group and the Yiqi Gubiao pill placebo control group. This will be followed by a 12-week treatment. During the treatment period, we will measure and record the patients' lung function and quality of life. We will also score the patients' TCM symptoms. Finally, the safety of the medication will be assessed.

Interventions

  • Drug Yiqi Gubiao pill
    Take 10 pills orally each time, three times a day, after meals, for a continuous period of 12 weeks. Receiving basic treatment: standardized quadruple anti-tuberculosis therapy is administered, with Rifampicin, Isoniazid, Ethambutol, and Pyrazinamide used for the first 2 months, followed by Rifampicin and Isoniazid for the next 4 months.
  • Drug Yiqi Gubiao Pill placebo
    The placebo's appearance and content color are similar to that of Yiqi Gubiao Pill, with the main ingredients being starch and caramel. Take 10 pills orally each time, three times a day, after meals, for a continuous period of 12 weeks. Receiving basic treatment: standardized quadruple anti-tuberculosis therapy is administered, with Rifampicin, Isoniazid, Ethambutol, and Pyrazinamide used for the first 2 months, followed by Rifampicin and Isoniazid for the next 4 months.

Primary outcome measures

  • Forced Vital Capacity [Time frame: up to 4 weeks]
  • the percentage of FVC predicted [Time frame: up to 4 weeks]
  • the ratio of FEV1 to FVC [Time frame: up to 4 weeks]
  • COPD Assessment Test (CAT) score [Time frame: up to 4 weeks]
  • modified Medical Research Council (mMRC) score [Time frame: up to 4 weeks]
  • Baseline Dyspnea Index (BDI) score [Time frame: up to 4 weeks]
  • Transition Dyspnea Index (TDI) score [Time frame: up to 4 weeks]
Secondary outcome measures (6)
  • Traditional Chinese Medicine (TCM) symptom score [Time frame: up to 4 weeks]
  • alanine aminotransferase [Time frame: up to 4 weeks]
  • aspartate aminotransferase [Time frame: up to 4 weeks]
  • urea nitrogen [Time frame: up to 4 weeks]
  • serum creatinine [Time frame: up to 4 weeks]
  • uric acid [Time frame: up to 4 weeks]

Eligibility criteria

Inclusion criteria

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Patients who meet the following criteria will be included:

  • Age 40-75 years old;
  • Meet the Western medical diagnostic criteria and typing standards for active PTB;
  • Patients who have not taken steroids, anti-tuberculosis drugs, or other immunosuppressants and have not undergone desensitization treatment within one month.
  • Have understood the treatment methods and voluntarily signed the informed consent form.

Exclusion criteria

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Patients who meet any of the following criteria will be excluded:

  • Patients with pneumothorax, pleural effusion, lung cancer and other serious lung diseases;
  • Patients with severe cardiovascular and cerebrovascular, hepatorenal and hematopoietic diseases;
  • mentally ill;
  • Patients with tumors;
  • Congenital or acquired immunodeficiency.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Bagcchi S. WHO's Global Tuberculosis Report 2022. Lancet Microbe. 2023 Jan;4(1):e20. doi: 10.1016/S2666-5247(22)00359-7. Epub 2022 Dec 12. No abstract available. PMID 36521512
  • Dai J, Zhang Y, Su J, Yuan G, Li F, Zhou Z, Aziza, Ye C, Seyiti A, Pida M, Zhang J. Yiqi Gubiao Pill for tuberculosis-associated obstructive pulmonary disease: protocol for a double-blind randomized controlled trial. Front Pharmacol. 2025 Oct 8;16:1610889. doi: 10.3389/fphar.2025.1610889. eCollection 2025. PMID 41132532

Identifiers

NCT: NCT06676800 · 2021D01C215

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗