Tuberculosis-related Obstructive Pulmonary Disease
Conditions
Keywords
Pulmonary tuberculosis, Yiqi Gubiao Pills, Chronic Obstructive Pulmonary Disease, Randomized double-blind placebo-controlled trial
Brief summary
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
DRUGYiqi 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.
DRUGYiqi 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.
Sponsors
Beijing University of Chinese Medicine
Fourth Affiliated Hospital of Xinjiang Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\- Patients who meet the following criteria will be included: 1. Age 40-75 years old; 2. Meet the Western medical diagnostic criteria and typing standards for active PTB; 3. Patients who have not taken steroids, anti-tuberculosis drugs, or other immunosuppressants and have not undergone desensitization treatment within one month. 4. Have understood the treatment methods and voluntarily signed the informed consent form.
Exclusion criteria
\- Patients who meet any of the following criteria will be excluded: 1. Patients with pneumothorax, pleural effusion, lung cancer and other serious lung diseases; 2. Patients with severe cardiovascular and cerebrovascular, hepatorenal and hematopoietic diseases; 3. mentally ill; 4. Patients with tumors; 5. Congenital or acquired immunodeficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transition Dyspnea Index (TDI) score | up to 4 weeks | 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. |
| Forced Vital Capacity | up to 4 weeks | Forced Vital Capacity (FVC) refers to the volume of air exhaled as quickly and forcefully as possible after taking the maximum inhalation. |
| the percentage of FVC predicted | up to 4 weeks | 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. |
| the ratio of FEV1 to FVC | up to 4 weeks | 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). |
| COPD Assessment Test (CAT) score | up to 4 weeks | 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. |
| modified Medical Research Council (mMRC) score | up to 4 weeks | 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. |
| Baseline Dyspnea Index (BDI) score | up to 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| alanine aminotransferase | up to 4 weeks | The reference range is 0-40 U/L. |
| aspartate aminotransferase | up to 4 weeks | The reference range is 0-40 U/L. |
| urea nitrogen | up to 4 weeks | Reference range value 3.2-7.1 mmol/L |
| serum creatinine | up to 4 weeks | Reference range value: Males 53-106 μmol/L, Females 44-97 μmol/L |
| uric acid | up to 4 weeks | Normal serum uric acid values: for adult males, 149-416 μmol/L; for adult females, 89-357 μmol/L. |
| Traditional Chinese Medicine (TCM) symptom score | up to 4 weeks | 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. |
Contacts
Primary ContactJin Dai, Attending Physician
Outcome results
None listed