silicosis
Conditions
Interventions
accelerated silicosis group:tetrandrine tablets
chronic silicosis group:tetrandrine tablets
placebo group:placebo
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 to 70 years, no restriction on gender; 2. Silicosis patients meeting the diagnostic criteria of pneumoconiosis GBZ 70-2015; 3. FVC >= 40% predicted at the time of screening; 4. DLCO >= 30% predicted at the time of screening; 5. Subject agrees to and signs the informed consent, and is able to comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with both artificial quartz dust exposure and other dust exposure; 2. Patients who will continue to do the work with dust exposure; 3. Patients with other interstitial lung diseases except silicosis; 4. Patients with asthma, or at the time of screening, the absolute value of FEV1 increased by more than 200ml or 12% after bronchodilator inhalation compared with before; 5. Patients with active pulmonary tuberculosis or spontaneous pneumothorax; 6. Patients with co-infection or high fever within 4 weeks before screening, including but not limited to acute bronchitis, pneumonia, sinusitis, urinary tract infection or cellulitis; 7. Patients requiring mechanical ventilation; 8. Patients who can't accomplish pulmonary function tests at the time of screening; 9. Dyskinesia caused by heart, nervous system, bone and joint system diseases; 10. Patients with unstable or worsening heart diseases within 6 moths before screening, including but not limited to the following situation: (1) Unstable angina pectoris or myocardial infraction; (2) Congestive heart failure patient who needs hospitalization; (3) Severe arrhythmia which is out of control; 11. Patients with other serious diseases. 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; 12. Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal, or total bilirubin > 1.5 times the upper limit of normal patients; 13. Abnormal renal function: creatinine exceeds the upper limit of normal value by 1.2 times, or creatinine clearance rate < 50mL/min (Cockcroft-Gault); 14. Patients who used cytokine regulating drugs, receptor antagonist drugs, TNF-a inhibitor or tyrosine kinase inhibitors within 1 month before screening; 15. Patients who used interferon, pirfenidone, nidanib or other antifibrotic drugs within 1 month before screening; 16. Patients who used glucocorticoid continuously for more than 7 days within 1 month before screening; 17. Patients of pregnant or lactating, or female subjects of childbearing age who have no effective contraceptive measures during the period of study; 18. Participating in other clinical trials within 3 months prior to participating in this study; 19. 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; 20. Patients who are allergic to the drug or its ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging changes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Forced vital capacity, %FVC%;Forced expiratory volume in one second;Chronic obstructive pulmonary disease evaluation test score;TNF-a;IL-6;6 minute walk test; | — |
Countries
China
Contacts
Public ContactShaowei Zhou
Shanghai Pulmonary Hospital
Outcome results
None listed