Interstitial Lung Disease (ILD)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Subjects voluntarily participate in this study and sign a written informed consent prior to entering the study; (2) Male or female subjects aged = 18 years; (3) Evaluation of HRCT completed during screening or within 12 months prior to screening, meeting Western medical diagnostic criteria for ILD; (4) Comply with the Chinese medicine diagnostic criteria for consumptive lung disease with qi deficiency and blood stasis syndrome; (5) Subjects with stable disease and mild to moderate pulmonary impairment (FVC%: 50%-80%, TLC%: 30%-80%, DLCO%: 40%-80%); (6) 6WMT = 100 m without adjunctive support.
Exclusion criteria
Exclusion criteria: (1) Allergic reaction to the drugs applied in this study; (2) Scheduled for lung transplantation within 6 months; (3) Patients who are participating in other drug clinical trials or interventional studies; (4) Combination of clinically significant respiratory diseases other than ILD (e.g., asthma, chronic obstructive pulmonary disease, lung cancer, active tuberculosis, bronchiectasis, pulmonary hypertension, etc.) (5) Combination of serious life-threatening diseases of the heart, brain, liver, kidney, and hematopoietic system, as evidenced by: ?heart: New York Heart Association (NYHA) cardiac function class III-IV; ? kidney: renal insufficiency or history of renal injury; or creatinine clearance 10%)]; (6) Those who have undergone chest, abdominal, and ophthalmic surgery in the last 3 months; (7) Women who are pregnant, lactating, or planning to become pregnant; (8) Patients with mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced Vital Capacity, FVC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of difficulty breathing;quality of life;Gastroesophageal reflux condition;Traditional Chinese Medicine Syndrome Points;6-minute walk test;Arterial blood gas/fingertip oxygen saturation; | — |
Countries
China
Contacts
China-Japan Friendship Hospital