Pneumoconiosis
Conditions
Interventions
The experimental group:Basic clinicai treatment+Jinbei oral liquid, 40ml each time, 3 times a day
The control group:Basic clinicai treatment+Jinbei oral liquid simulator, 40ml each time, 3 times a day
Sponsors
Shandong First Medical University affiliated occupational disease Hospital(Shandong Occupational Disease Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old and =30% at screening; 4. Patients with the percentage of diffusing carbon monoxide to the predicted value DLco% at screening>=30%; 5. TCM syndrome differentiation is qi and yin deficiency and phlegm and stasis obstruction syndrome; 6. Voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who continue to engage in work exposed to dust; 2. Patients with other interstitial lung diseases; 3. Patients with active tuberculosis, or spontaneous pneumothorax; 4. Patients with a history of asthma or an increase in the absolute value of FEV1 after bronchodilators of more than 200ml and an increase of >=12% of FEV1 compared with before the use of bronchodilators at screening; 5. Patients requiring long-term home oxygen therapy or supplemented with mechanical ventilation; 6. Patients with other major diseases. Critical illness is defined as: according to the judgment of the investigator, because participation in a clinical study can put the patient at risk, affect the results of the trial, or the patient's ability to participate in the trial, such as serious heart, brain, liver, kidney, hematologic system disease or malignant tumor, etc.; 7. Abnormal liver function: patients with alanine aminotransferase ALT and aspartate aminotransferase AST > 2 times the upper limit of normal, or patients with total bilirubin > 1.5 times the upper limit of normal; 8. Patients with abnormal renal function: creatinine exceeding the upper limit of normal value by 1.2 times, or creatinine clearance CrCl 10mmol/L); 10. Patients who have used pirfenidone and nintedanib within 1 month before randomization, and patients who have used oral or intravenous glucocorticoids for more than 7 days within 2 weeks before enrollment; 11. Pregnant, lactating, or planning to conceive or lactate during the study; 12. Participated in other clinical trials within 3 months before participating in this study; 13. History of unstable or worsening cardiac disease within the past 6 months, including but not limited to the following: a) unstable angina pectoris or myocardial infarction; b) congestive heart failure requiring hospitalization; c) uncontrollable clinically significant arrhythmias; 14. For patients with acute exacerbation 1 month before enrollment, the diagnostic criteria for acute exacerbation are: dyspnea with typical acute deterioration or progression within 1 month, and X-ray chest X-ray shows the progression of diagnostic stage; 15. Patients with alcohol allergy; 16. Patients with moderate to severe depression or anxiety (Depression Self-Rating Scale (SDS) > 63 points, Anxiety Self-Rating Scale (SAS) > 60 points).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of FEV1, FVC and TLC from baseline and differences between groups after treatment;The changes of TCM syndrome score before and after treatment, the changes of TCM syndrome efficacy evaluation before and after treatment, and the changes of individual TCM syndrome efficacy evaluation before and after treatment;Changes of FEV1%, FEV1/FVC % and DLCO % from baseline after treatment and differences between groups;The number of respiratory infections;Changes of SGRQ score from baseline after treatment;Changes in arterial partial oxygen pressure (PaO2) from baseline;Changes in SpO2 from baseline after treatment;Chest X-ray and HRCT showed changes in the lung lesion area; | — |
Countries
China
Contacts
Public ContactCui Ping
Shandong First Medical University affiliated occupational disease Hospital(Shandong Occupational Disease Hospital)
Outcome results
None listed