Idiopathic pulmonary fibrosis
Conditions
Interventions
The experimental group:Jinbei oral liquid, 40ml each time, 3 times a day
Bailing capsule, 2 capsules each time, 3 times daily.
The control group:Jinbei oral liquid simulator, 40ml each time, 3 times a day
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All the following criteria must be met when entering the group. 1. Clinical or multidisciplinary discussion on the confirmed IPF patients, and chest HRCT examination during the screening period; 2. Subjects with FVC% between 50% and 90% of normal predicted value and DLCO >=30% of normal predicted value; 3. The subjects with FEV1 / FVC >=70%; 4. Those who are expected to survive for more than one year; 5. The subjects of Qi Yin deficiency and Phlegm Blood Stasis Syndrome Differentiation in TCM; 6. Aged 18 to 79 years old; 7. The subjects who voluntarily participate in this clinical trial should give informed consent and sign informed consent.
Exclusion criteria
Exclusion criteria: Compliance with any of the following criteria is excluded. 1. The subjects whose symptoms of dyspnea were relieved in the past 6 months; 2. Patients with acute exacerbation of IPF within 6 months before screening or during screening; 3. The subjects who had used pirfenidone and nidanib within 4 weeks before screening; 4. Patients who received any of the following treatments within 4 weeks before screening, during screening or during the planned study period: acetylcysteine, angiotensin converting enzyme inhibitor, heparin, warfarin, imatinib, ambesantan, azathioprine, cyclophosphamide and cyclosporin A. Interferon, penicillamine, colchicine, bosentan, masetiptan, methotrexate, sildenafil (except for occasional use), prednisone (> 15 mg / day or 10mmol / L); 6. Patients with malignant tumor, cerebral hemorrhage or other bleeding prone diseases; 7. Patients with NYHA grade III and above; 8. Patients with other severe lung diseases or severe heart, brain, liver (AST or ALT > 1.5 times of the upper limit of normal reference value), kidney (SCR > upper limit of normal reference value), gastrointestinal tract, active infection, hematopoiesis or endocrine system and mental disease; 9. Pregnant or lactating women, subjects of childbearing age (including male subjects who have heterosexual behavior and their female partners with reproductive potential) who have pregnancy plan or are unwilling to take effective contraceptive measures during the study period; 10. Subjects who were unwilling to quit smoking during the study period; 11. Subjects suspected or having a history of alcohol and drug abuse; 12. Subjects known or suspected to have allergic history to the test drug and its excipients; Other subjects who participated in the clinical trials within 13 months before the screening; 14. Risk of thrombosis, subjects with known genetic predisposition to thrombosis and history of thrombotic events (including stroke and transient ischemic attack) within 12 months before enrollment; 15. Those who can't complete the questionnaire answer independently (including those who can't understand and abide by it); 16. The researchers consider it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute exacerbation events (frequency and severity);No disease progression time;Changes in 6-minute walking distance from baseline at 12 and 26 weeks after treatment;Changes in SpO2 from baseline at 4, 12, and 26 weeks after treatment;Changes of SGRQ (St 'George Hospital Respiratory Problems Questionnaire) scores from baseline after 12 and 26 weeks of treatment;Changes of TCM syndrome score from baseline after 4 weeks, 12 weeks and 26 weeks of treatment;Treatment endpoint events associated with pulmonary fibrosis (e.g. number of deaths); | — |
Secondary
| Measure | Time frame |
|---|---|
| HRCT at 12 weeks and 26 weeks after treatment showed changes in the lung stroma compared with that at baseline;Changes of lung function (TLC, FVC, FVC %, FEV1, DLco, DLco/VA) from baseline after 12 and 26 weeks of treatment;Changes in arterial blood gas analysis (PaO2) from baseline after 12 and 26 weeks of treatment; | — |
Countries
China
Contacts
Public ContactLi Huaichen
Shandong Provincial Hospital
Outcome results
None listed