NCT07319598

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This multicenter, randomized, double-blind, placebo-controlled study enrolls 100 adults with connective tissue disease-related interstitial lung disease. Patients are randomized 1:1 to receive tetrandrine tablets (60 mg TID) or placebo for 24 weeks, alongside standard treatment. The primary outcome is the change in forced vital capacity (FVC) at 24 weeks. Secondary outcomes include changes in serum inflammatory markers (TGF-β1, KL6, TNF-α, IL-6), lung HRCT scores, other Lung function parameters (TLC, VC, DLCO, PaO2), St. George's Respiratory Questionnaire (SGRQ) score, safety parameters, and all-cause mortality. Visits occur at weeks 4, 8, 12, and 24 for efficacy and safety assessments.

Conditions

• Interstitial Lung Disease (ILD)
• Connective Tissue Disease-associated Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	Tetrandrine Tablets	60 mg (3 tablets, 20 mg each), orally three times daily (TID) for 24 weeks, with glucocorticoids and immunosuppressants
DRUG	Placebo	Placebo tablets mimicking tetrandrine, 3 tablets TID, orally for 24 weeks, with glucocorticoids and immunosuppressants

Timeline

• Start date: 2023-11-02
• Primary completion: 2026-10-15
• Completion: 2027-01-01
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: China