NCT06861179

The Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis

Basic and Clinical Studies on the Effects of the Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this clinical trial were to determine the radioprotective effects and underlying biological mechanisms of Phellinus igniarius and its active components during radiotherapy in patients with thoracic malignant tumors. The study group was given the formulation of Compound Phellinus igniarius decoction daily during radiotherapy, 150ml bid until the end of radiotherapy; The control group only received standard dose radiotherapy without the formulation of Compound Phellinus igniarius decoction intervention. The baseline differences between the two groups were compared, including gender, smoking history, body mass index (BMI), pathological classification, median age of onset, inflammatory factors, tumor markers, TNM stage, KPS score, fatigue score, incidence and grade of radiation pneumonitis, incidence of other radiotherapy-related adverse reactions, and average radiation dose.

Detailed description

Investigators measured the levels of inflammatory factors and tumor markers in blood samples of patients in the two income groups, and administered questionnaires on the degree of fatigue and general status of patients. Metabolite changes and gut microbiota homeostasis in patient fecal samples were then detected by untargeted metabolomics and metagenomics.

Conditions

• Radiation Pneumonitis

Interventions

Type	Name	Description
DRUG	The formulation of Compound Phellinus igniarius decoction	The formulation of Compound Phellinus igniarius decoction is manufactured by Hangzhou Qianjifang Technology Co., Ltd, the composition includes Phellinus igniarius 12g, jujube 3g, wolfberry 3g, tangerine peel 1g. The dosage regimen was as follows: 4 Packs of the formulation of Compound Phellinus igniarius decoction (Phellinus igniarius Herbal Decoction Pieces) + 1 Pack of the formulation of Compound Phellinus igniarius decoction(Excipients) per day, administered twice daily throughout the entire course of radiotherapy until its completion.

Timeline

• Start date: 2023-03-22
• Primary completion: 2024-12-28
• Completion: 2024-12-28
• First posted: 2025-03-06
• Last updated: 2025-03-11

Locations

1 site across 1 country: China