Randomized Trial Protocol: Yifei Sanjie Pill for Preventing High-Risk Pulmonary Nodule Progression

A multicenter RCT is testing whether adding Yifei Sanjie Pill to CT surveillance reduces 2-year progression of high-risk subsolid pulmonary nodules (≤8 mm). 589 participants randomized; primary results expected 2028.

• Design: 1:1 randomized, double-blind, placebo-controlled trial of Yifei Sanjie Pill granules vs placebo for 6 months, with 2-year CT follow-up.
• Primary endpoint: 2-year nodule progression rate (≥2 mm increase in longest diameter, ≥1 mm solid component increase, or new solid component).
• Study enrolled 589 adults with mixed ground-glass nodules ≤8 mm; primary analysis will use Kaplan-Meier and Cox regression; results pending.

Automated summary

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