interstitial lung disease
Conditions
Interventions
Control Group:Conventional treatment for interstitial lung disease
Experimental group:Conventional treatment for interstitial lung disease combined with a modified Dangshen Pingfei Huoxue Decoction.
Sponsors
Jiangsu Province Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meeting the diagnostic criteria for interstitial lung disease (ILD). 2. Meeting the diagnostic criteria for the traditional Chinese medicine (TCM) syndrome of Qi deficiency and blood stasis. 3. Aged between 40 and 80 years (inclusive) with no restriction on sex. 4. Forced vital capacity (FVC) = 50% of the predicted value and diffusing capacity of the lung for carbon monoxide (DLCO) = 30% of the predicted value. 5. Six-minute walk test (6MWT) distance = 150 meters. 6. Ability to understand and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of asthma or chronic obstructive pulmonary disease (COPD). 2. Patients with clinical evidence of active infection including but not limited to bronchitis pneumonia sinusitis urinary tract infection or cellulitis. 3. A history of malignancy that may result in severe disability or require major medical or surgical intervention within the next two years. 4. Any condition other than interstitial lung disease (ILD) that in the investigator's judgment may lead to death within the next two years. 5. A history of severe hepatic dysfunction or end-stage liver disease. 6. A history of end-stage renal disease requiring dialysis. 7. Unstable or worsening cardiac or pulmonary disease (excluding ILD) within the past six months. 8. Pregnancy or breastfeeding. 9. A history of alcohol or drug abuse within the past two years. 10. Abnormal liver function tests exceeding the specified limits including: total bilirubin above the upper limit of normal (ULN); or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × ULN. 11. Prior use of traditional Chinese medicine specifically for ILD or known allergy to any component of Dangshen Pingfei Huoxue Decoction. 12. Participation in any investigational drug study for an unapproved indication within 28 days prior to screening. 13. Current use of any of the following medications for the management of autoimmune diseases: azathioprine cyclosporine mycophenolate mofetil tacrolimus oral corticosteroids > 20 mg/day or combinations of oral corticosteroids azathioprine and N-acetylcysteine; cyclophosphamide; or rituximab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pulmonary function; | — |
Secondary
| Measure | Time frame |
|---|---|
| University of California, San Diego Shortness of Breath Questionnaire;Serum Krebs von den Lungen-6;Time to first acute exacerbation and the number of acute exacerbations;Serum N-terminal propeptide of type III procollagen;Serum type IV collagen;St. George's Respiratory Questionnaire;Serum hyaluronic acid;6-Minute Walk Test; | — |
Countries
China
Contacts
Public ContactXianmei Zhou
Jiangsu Province Hospital of Chinese medicine
Outcome results
None listed