A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Tetrandrine Tablets in Treating Interstitial Lung Disease Related to Connective Tissue Disease
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.
• 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
• Fertile male or female patients must agree to use effective contraception from signing informed consent until 3 months after the last study drug dose (Exemptions: postmenopausal women \>50 years with amenorrhea for \>1 year, or surgically sterilized women)
• Patients on stable doses of prednisone (≤20 mg/day or equivalent) or immunosuppressants for at least 4 weeks prior to study entry, with dose adjustments not exceeding this during the double-blind period