NCT06747325

Clinical Trial of Fei Re Qing Granules in the Treatment of Elderly Community-Acquired Pneumonia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Fei Re Qing Granules in the Treatment of Elderly Community-Acquired Pneumonia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the clinical efficacy of traditional Chinese medicine formula granules (Fei Re Qing Granules) in the treatment of elderly community-acquired pneumonia, establish a treatment protocol, and obtain high-level clinical evidence.

Detailed description

This study evaluates the efficacy and safety of Fei Re Qing Granules for elderly community-acquired pneumonia (CAP) through a multicenter, randomized, double-blind, placebo-controlled trial. Key elements of the trial include: Design: Conducted across multiple centers, comparing treatment and placebo groups. Participants: Patients aged 65-80 years diagnosed with CAP according to both Western and Traditional Chinese Medicine (TCM) diagnostic criteria. Intervention: Test group: Fei Re Qing Granules administered alongside standard CAP treatments. Control group: Placebo granules matching the appearance and composition of the active granules, plus standard treatments. Outcomes: Primary efficacy indicator: Time to clinical stability. Secondary indicators: Symptom improvement, hospital stay length, and imaging-based inflammation resolution. TCM-specific indicators assess syndrome improvements and integrate modern scoring methods (e.g., CURB-65). Study Duration: Two 7-day treatment cycles with 12-week follow-ups. This trial seeks to establish robust evidence for integrating Fei Re Qing Granules into TCM-based CAP management strategies

Conditions

• Community-Acquired Pneumonia (CAP)

Interventions

Type	Name	Description
DRUG	Fei Re Qing Granules	Fei Re Qing Granules (Ingredients: Scutellaria baicalensis \[Huang Qin\], Trichosanthes kirilowii \[Gua Lou\], Forsythia suspensa \[Lian Qiao\], Fritillaria thunbergii \[Zhe Bei Mu\], etc.)
OTHER	Routine standard treatments	Routine standard treatments
DRUG	Placebo granules	The placebo granules are prepared using 5% of the active drug, ensuring consistency in appearance, weight, color, and odor with the Fei Re Qing Granules

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2024-12-24
• Last updated: 2024-12-24