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
Sponsor study identifier
interventional
100
1 country
1
Study Start
November 2, 2023
Actual (reported)Primary Completion
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2, 2023
Actual (reported)August 27, 2025
Actual (reported)January 6, 2026
Actual (reported)October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Forced Vital Capacity (FVC)
Change in forced vital capacity (FVC) expressed in liters (L) of predicted normal value, measured using a pulmonary function testing device in accordance with ATS/ERS standards at a central facility. Units: Absolute value（L）
Baseline to 24 weeks
Change in Serum Transforming Growth Factor Beta 1 (TGF-β1) Level
Baseline to 24 weeks
Change in Serum Krebs von den Lungen-6 (KL6) Level
Baseline to 24 weeks
Change in Serum Tumor Necrosis Factor Alpha (TNF-α) Level
Baseline to 24 weeks
Change in Serum Interleukin-6 (IL-6) Level
Baseline to 24 weeks
Change in Semi-Quantitative High-Resolution Computed Tomography (HRCT) Score
Baseline to 24 weeks
Participants receive tetrandrine tablets (60 mg, three times daily) for 24 weeks, along with standard treatment (glucocorticoids and immunosuppressants).
Participants receive placebo tablets (mimicking tetrandrine, three times daily) for 24 weeks, along with standard treatment (glucocorticoids and immunosuppressants).
60 mg (3 tablets, 20 mg each), orally three times daily (TID) for 24 weeks, with glucocorticoids and immunosuppressants
Placebo tablets mimicking tetrandrine, 3 tablets TID, orally for 24 weeks, with glucocorticoids and immunosuppressants
Peking University Third Hospital
Beijing, China
First Submitted
August 27, 2025
First Posted
January 6, 2026
Study Start
November 2, 2023
Actual (reported)Primary Completion
October 15, 2026
Estimated (date passed)Efficacy and Safety of Pirfenidone in CTD-ILD
Gabapentin vs. Benzonatate vs. Standard of Care for Cough in ILD
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 6, 2026
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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