Observation of therapeutic effect of Bailing tablets on connective tissue disease related interstitial lung disease
- Conditions
- Connective tissue disease-related interstitial lung disease
- Registration Number
- ITMCTR2000003412
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Patients diagnosed as interstitial lung disease related to connective tissue disease meet the international general diagnostic criteria;
2. Patients in stable stage with mild to moderate lung function impairment;
3. Patients aged 40-85 years;
4. patients who did not participate in the clinical study of other drugs in the past month;
5. The process of obtaining informed consent for the subjects with informed consent and voluntary consent conforms to the provisions of GCP.
1. Patients with severe lung function impairment, or unable to complete lung function test;
2. Patients with other serious pulmonary diseases, such as COPD, asthma, tuberculosis, lung cancer, bronchiectasis, pulmonary hypertension, etc;
3. Patients who received lung volume reduction surgery within 12 months before previous pneumonectomy or screening;
4. Patients with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, and mental diseases;
5. Patients who are allergic to any component of the test drug or who are allergic to more than 2 kinds of food or drugs;
6. Patients who are not considered suitable for the clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Annual decline rate of forced vital capacity (FVC);Number of hospital admissions with acute exacerbation;
- Secondary Outcome Measures
Name Time Method TCM syndrome scores;St. George's Respiratory Questionnaire;pulmonary function test (TLC, FEV1, DLco);6 minutes walk distance;Immune function indicators (proportion of T lymphocytes, humoral immune function, complement);