NCT06766565

QYJD Compound Preparation Promotes Rapid Postoperative Recovery in Early-stage NSCLC Patients by Regulating Tissue Microecology: a Prospective, Randomized Controlled, Open-label, Phase I Clinical Study With Predefined Future Exploration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Fuzhou General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

QYJD compound preparation has the efficacy of clearing heat and removing toxins, dispelling blood stasis and relieving pain, etc. investigators aimed to explore the effect of expelling blood stasis and removing toxins compound preparation on the microecological changes of lungs of patients with early stage non-small cell lung cancer (NSCLC) by using metagenomics next-generation sequencing (mNGS) technology to carry out a prospective phase I clinical study. The aim of the study was to investigate the effect of the expelling stasis and detoxifying compound preparation on the microecology of lungs of patients with early-stage non-small cell lung cancer (NSCLC), and to conduct a prospective phase I clinical study to provide new ideas for promoting the postoperative rehabilitation of early-stage NSCLC.

Detailed description

1. participants screened for eligibility should sign the appropriate Informed Consent Form (ICF) prior to completing any study procedures. 2. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	QYJD Compound Preparation	The intervention group was treated with 2 capsules (g) of expelling stasis and QYJD compound preparation orally for 4 days before thoracoscopic radical surgery for lung cancer, 3 times a day. The blank control group had no oral drug treatment before surgery.

Timeline

• Start date: 2021-12-08
• Primary completion: 2022-12-08
• Completion: 2023-12-08
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: China