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

Phase 1

Completed

• Conditions: NSCLC
• Interventions: Drug: QYJD Compound Preparation

• Registration Number: NCT06766565
• Lead Sponsor: Fuzhou General Hospital

Brief 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.

Study Timeline

• Study Start: 2021-12-08
• Primary Completion: 2022-12-08
• Study Completion: 2023-12-08
• Study First Submitted: 2024-11-15
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-04
• Last Update Submitted: 2025-01-04
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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Exclusion Criteria

1. the presence of malignant tumors or metastatic foci in other parts of the body;
2. the combination of other organic diseases;
3. psychiatric disorders or communication disorders;
4. lung infections, systemic hematologic diseases, immune system diseases;
5. bronchodilatation, bronchial asthma, or chronic obstructive pulmonary disease and other underlying lung diseases;
6. within the past month, there are antibiotics, immunosuppressive drugs, hormones, probiotics, as well as any those who have taken antibiotics, immunosuppressants, hormones, probiotics, and any form of traditional Chinese medicine or proprietary Chinese medicine within the past month;
7. Those who have a history of smoking;
8. Those who have a history of occupational or environmental exposure to dust, mines, or asbestos.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QYJD Compound Preparation intervention group	QYJD Compound Preparation	Group2 In the treatment group, the patients were orally treated with expelling blood stasis and detoxifying compound preparation for 4 days before thoracoscopic radical lung cancer surgery, 2 capsules (0.3g/capsule) at a time, 3 times a day, with lukewarm water, for a total of 4 days.Patients were treated with anti-inflammatory and analgesic therapy postoperatively on a case-by-case basis.

Primary Outcome Measures

Name	Time	Method
Rapid rehabilitation indexes	7 day	six-minute walking experiments
Laboratory indicators of inflammation	through study completion, an average of 1 year	including white blood cell count, neutrophil count, lymphocyte count, platelet count, NLR, PLR

Trial Locations

Locations (1)

Zongyang Yu; 🇨🇳 Fujian, Fuzhou, China