A Study to Test Tetrandrine Tablets for Connective Tissue Disease-Related Lung Disease

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Third Hospital

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

Treatment groups

100 Participants
are divided into 2 treatment groups