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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Forced Vital Capacity [Срок оценки: up to 4 weeks]
• the percentage of FVC predicted [Срок оценки: up to 4 weeks]
• the ratio of FEV1 to FVC [Срок оценки: up to 4 weeks]
• COPD Assessment Test (CAT) score [Срок оценки: up to 4 weeks]
• modified Medical Research Council (mMRC) score [Срок оценки: up to 4 weeks]
• Baseline Dyspnea Index (BDI) score [Срок оценки: up to 4 weeks]
• Transition Dyspnea Index (TDI) score [Срок оценки: up to 4 weeks]

Вторичные конечные точки (6)

• Traditional Chinese Medicine (TCM) symptom score [Срок оценки: up to 4 weeks]
• alanine aminotransferase [Срок оценки: up to 4 weeks]
• aspartate aminotransferase [Срок оценки: up to 4 weeks]
• urea nitrogen [Срок оценки: up to 4 weeks]
• serum creatinine [Срок оценки: up to 4 weeks]
• uric acid [Срок оценки: up to 4 weeks]

Критерии участия

Критерии включения

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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.

Критерии исключения

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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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06676800 · 2021D01C215

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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