Pneumoconiosis
Conditions
Interventions
control group:placebo
Sponsors
Shanghai Pulmonary Hospital, Tongji Univiersity
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age range of 18 to 70, no restriction on gender; 2. Pneumoconiosis patients meeting the diagnostic criteria of pneumoconiosis GBZ 70-2015 (Limited to silicosis and coal worker's pneumoconiosis); 3. FEV1% = 40% predicted at the time of screening; 5. SaO2 >= 60% at the time of screening; 6. DLCO >= 30% predicted at the time of screening; 7. Subject agrees to and signs the informed consent and is able to comply with the study procedures. If both subject and legal guardian are unable to read and understand the informed consent, the consent shall be signed by a third party witness.
Exclusion criteria
Exclusion criteria: 1. Patients who continue to engage in dust exposure work; 2. Patients with pneumoconiosis other than silicosis and coal worker's pneumoconiosis; 3. Patients with interstitial lung diseases except pneumoconiosis; 4. Patients with active pulmonary tuberculosis, or with spontaneous pneumothorax; 5. Patients with co-infection or high fever within 4 weeks before screening, including but not limited to respiratory virus infection, pulmonary mycosis, acute bronchitis, pneumonia, sinusitis, urinary tract infection or cellulitis; 6. Patients with a history of asthma or at the time of screening, the absolute value of FEV1 increased by more than 200ml or 12% after bronchodilator compared with before bronchodilator; 7. Patients who are unable to complete lung function tests at the time of screening; 8. Patients requiring long-term home oxygen therapy or mechanical ventilation; 9. Patients with other serious illnesses. Serious disease is defined as a disease or condition, such as severe disease of the heart, brain, liver, kidney, blood system, or malignant tumor, that, in the judgment of the investigator, puts the patient at risk for participating in a clinical study and affects the outcome of the study or the patient's ability to participate in the study; 10. Abnormal liver function: alanine aminotransferase or ALT aminotransferase AST > 2 times the upper limit of normal, or total bilirubin > upper limit of normal patients. 11. Abnormal renal function: creatinine exceeds the upper limit of normal value by 1.2 times, or creatinine clearance rate < 50mL/min (Cockcroft-Gault); 12. Patients who used Bailing Capsule, Jinshuibao, Pneumoconiosis Pill, Yinhuangqingfei Capsule, Qishengyiqi Dropping Pill, Yixinkangtai Capsule, or Bufei Huoxue Capsule within 1 month before randomization; Randomized patients who had used tonic lung and invigorating blood capsules in the previous 1 month; 13. Patients of pregnant or lactating, or female subjects of childbearing age who have no effective contraceptive measures during the period of study; 14. Participating in other clinical trials within 3 months prior to participating in this study; 15. Patients who are not eligible to participate in clinical trials according to the investigator, including those with existing physical or psychological conditions that preclude adherence to the protocol; 16. Patients who are allergic to the drug or its ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FVC%; | — |
Secondary
| Measure | Time frame |
|---|---|
| SaO2%;CAT;mMRC;D-dimer;fibrinogen;TNF-a;IL-6;N-BNP;6MWT; | — |
Countries
China
Contacts
Public ContactLing Mao
Department of Pneumoconiosis, Shanghai Pulmonary Hospital Affiliated to Tongji University
Outcome results
None listed