About this trial
This study evaluates the efficacy and safety of tetrandrine tablets (60 mg, three times daily) compared to placebo in adult patients with connective tissue disease-related interstitial lung disease. Patients receive standard treatment (glucocorticoids and immunosuppressants) alongside the study drug or placebo for 24 weeks. The study measures changes in lung function, inflammatory markers, lung imaging, quality of life, and safety outcomes.
Eligibility criteria
Qualifiers
Patients who voluntarily participate and sign the informed consent form
Male or female patients aged 18-80 years (inclusive)
Patients meeting the diagnostic criteria for connective tissue disease-related interstitial lung disease per the 2018 Chinese Expert Consensus at screening
FVC ≥40% of predicted value at screening
Disqualifiers
Treatment with tetrandrine or other antifibrotic drugs within 1 month before screening
Diabetes with fasting blood glucose greater than 11.1 mmol per L
Resting arterial oxygen partial pressure less than 50 mmHg
Active peptic ulcers or bleeding disorders
Trial design
Treatments tested in this trial
- Tetrandrine Tablets
- Placebo