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| Name | Class |
|---|---|
| Beijing University of Chinese Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yiqi Gubiao pill | Experimental |
| |
| Yiqi Gubiao Pill placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yiqi Gubiao pill | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Vital Capacity | Forced Vital Capacity (FVC) refers to the volume of air exhaled as quickly and forcefully as possible after taking the maximum inhalation. | up to 4 weeks |
| the percentage of FVC predicted | The volume of air exhaled rapidly within one second after inhaling to the total lung capacity. Normal values are 70-85%, mild is less than 80% of the predicted value; moderate is less than 70% of the predicted value; moderately severe is less than 60% of the predicted value; severe is less than 50% of the predicted value. | up to 4 weeks |
| the ratio of FEV1 to FVC | The ratio of FEV1 to FVC should be above 70%. If the ratio is below 70%, it may indicate the presence of chronic obstructive pulmonary disease (COPD). | up to 4 weeks |
| COPD Assessment Test (CAT) score | The CAT score questionnaire is primarily used to assess the health status and impact on daily life of patients with chronic obstructive pulmonary disease (COPD). It quantifies the degree of health impairment in COPD patients by asking questions related to symptoms, activity ability, mental state, and social impact based on the patients' self-reports. The total score of the CAT questionnaire ranges from 0 to 40, with higher scores indicating poorer health status and lower quality of life for the patients. | up to 4 weeks |
| modified Medical Research Council (mMRC) score | The mMRC is only used for the assessment of dyspnea and is often applied in conjunction with the CAT score. An mMRC score of 2 or above is the threshold for distinguishing "mild dyspnea" from "severe dyspnea." | up to 4 weeks |
| Baseline Dyspnea Index (BDI) score |
| Measure | Description | Time Frame |
|---|---|---|
| Traditional Chinese Medicine (TCM) symptom score | The main symptoms and secondary symptoms are graded from mild to severe into 4 levels. The main symptoms are scored 0, 2, 4, 6 points respectively, and the secondary symptoms are scored 0, 1, 2, 3 points respectively. The tongue and pulse are not scored. The sum of the scores for all symptoms is the total TCM symptom score. | up to 4 weeks |
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Inclusion Criteria:
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Patients who meet the following criteria will be included:
Exclusion Criteria:
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Patients who meet any of the following criteria will be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Dai, Attending Physician | Contact | 0316-17590826125 | daijintcm@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36521512 | Background | 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. | |
| 41132532 | Derived | 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. |
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| Yiqi Gubiao Pill placebo | Drug | 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. |
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It measures activity-related dyspnea from three dimensions: degree of functional impairment, amount of activity, and effort required to complete activities. Each dimension is graded on a 5-level scale, with scores ranging from 0 to 4, indicating increasing severity. The total score ranges from 0 to 12. |
| up to 4 weeks |
| Transition Dyspnea Index (TDI) score | The TDI should be used in conjunction with the BDI to measure the extent of change in prognostic functional impairment, activity level, and effort required to complete activities. The TDI scores each dimension on a scale from significantly worse (-3) to significantly better (+3), with a total score ranging from -9 to +9. | up to 4 weeks |
| alanine aminotransferase | The reference range is 0-40 U/L. | up to 4 weeks |
| aspartate aminotransferase | The reference range is 0-40 U/L. | up to 4 weeks |
| urea nitrogen | Reference range value 3.2-7.1 mmol/L | up to 4 weeks |
| serum creatinine | Reference range value: Males 53-106 μmol/L, Females 44-97 μmol/L | up to 4 weeks |
| uric acid | Normal serum uric acid values: for adult males, 149-416 μmol/L; for adult females, 89-357 μmol/L. | up to 4 weeks |
| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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