Yifei Sanjie Pill reduces the 2-year progression rate of high-risk pulmonary nodules in adults with mixed ground-glass nodules ≤8 mm.
This multicenter RCT protocol evaluates YFSJ versus placebo for preventing progression of high-risk pulmonary nodules over 2 years. The primary outcome is progression rate defined by ≥2 mm increase in diameter, ≥1 mm increase in solid component, or new solid component. The study enrolled 589 participants and will analyze results using Kaplan-Meier and Cox regression.
Evidence Score
Study Evidence
Study 1. Clinical Study on the Prevention of High-Risk Pulmonary Nodule Progression With Yifei Sanjie Pill: Protocol for a Multicenter Randomized Controlled Trial.
observationalAn B, Lin J, Wang J, Chen Z, Guan M, Li Y, Qi X, Sun L, Lin L · JMIR research protocols (2026)
Result:
Mechanism Graph
Limitations
- ⚠Results are not yet available; this is a protocol paper
- ⚠The study is ongoing with final analysis expected in 2028
- ⚠Placebo-controlled but blinding details not fully described
Frequently Asked Questions
What is Yifei Sanjie Pill?▼
YFSJ is an 8-herb traditional Chinese medicine formula previously studied as an adjunctive treatment for non-small cell lung cancer.
Who is eligible for this trial?▼
Adults aged 18–80 years with single or multiple mixed ground-glass nodules ≤8 mm.
What is the primary outcome of the study?▼
The 2-year pulmonary nodule progression rate, defined as an increase in lesion diameter ≥2 mm, increase in solid component ≥1 mm, or new solid component.
When will the results be available?▼
Database lock and primary analysis are planned for early 2028, with first results expected in spring or summer 2028.
Products
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References
- 1.An B, Lin J, Wang J, Chen Z, Guan M, Li Y, Qi X, Sun L, Lin L. "Clinical Study on the Prevention of High-Risk Pulmonary Nodule Progression With Yifei Sanjie Pill: Protocol for a Multicenter Randomized Controlled Trial.." JMIR research protocols, 2026. PMID: 42456132 DOI: 10.2196/78534