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Clinical Study on the Prevention of High-Risk Pulmonary Nodule Progression: Comparing Chinese Herbal Formula Granules of Yiqi Chutan Method with Traditional Decoction

Registration number：

ITMCTR2024000257

Date of Last Refreshed on：

2024-08-19

Date of Registration：

2024-08-19

Registration Status：

Prospective registration

Public title：

Clinical Study on the Prevention of High-Risk Pulmonary Nodule Progression: Comparing Chinese Herbal Formula Granules of Yiqi Chutan Method with Traditional Decoction

English Acronym：

Scientific title：

Clinical Study on the Prevention of High-Risk Pulmonary Nodule Progression: Comparing Chinese Herbal Formula Granules of Yiqi Chutan Method with Traditional Decoction

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Jietao Lin

Study leader：

Lizhu Lin

Applicant telephone：

+86 158 1332 6348

Study leader's telephone：

020-36591693

Applicant Fax：

Study leader's fax：

Applicant E-mail：

linjietao5049@gzucm.edu.cn

Study leader's E-mail：

gzucmlinlz@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

16 Airport Road, Baiyun District, Guangzhou, Guangdong

Study leader's address：

16 Airport Road, Baiyun District, Guangzhou, Guangdong

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

K-2023-122

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Date of approved by ethic committee：

2024/3/11 0:00:00

Contact Name of the ethic committee：

Yun Tang

Contact Address of the ethic committee：

Ethics Committee of The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Contact phone of the ethic committee：

+86 20 3658 8667

Contact email of the ethic committee：

gzucmlunli@163.cokm

Primary sponsor：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Primary sponsor's address：

16 Airport Road, Baiyun District, Guangzhou, Guangdong

Secondary sponsor：

Country：

People's Republic of China

Province：

Guangdong

City：

Guangzhou

Institution
hospital：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Address：

No.16 Airport Road, Baiyun District, Guangzhou City, Guangdong

Source(s) of funding：

Fundamental and Applied Basic Research Committee of Guangdong Province

Target disease：

pulmonary nodule

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

In this study, we compared the clinical efficacy and safety of "Yiqi Chutan Formula" Chinese medicine granules and tonics in treating patients with high-risk lung nodules. We explored the possible mechanism of "Yiqi Chutan Formula" in treating lung nodules.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1: Age between 18-80 years old (inclusive), gender not restricted; 2: Ground-glass or part-solid lung nodules ≤3cm in diameter, either solitary or multiple. 3: Subjects without major organ dysfunction, with normal blood routine, liver, kidney, and heart function tests. 4: Patients have signed the informed consent form, voluntarily accepting treatment and follow-up.

Exclusion criteria：

1: Malignant tumors that have not reached clinical cure and still require adjuvant therapy or palliative treatment; 2: Recent lung disease due to rheumatic immune disorders; presence of obstructive pneumonia, atelectasis, hilar enlargement, or pleural effusion; patients with hemoptysis or blood-tinged sputum, and patients with tuberculosis; 3: Pregnant or breastfeeding women; 4: Individuals with severe primary heart, liver, lung, kidney, blood diseases, or other serious illnesses affecting survival; patients with mental disorders or altered consciousness; 5: Those allergic to or intolerant of Chinese herbs and/or known components of the "Yiqi Chutan Formula"; 6: Individuals unable to comply with follow-up requirements.

Study execute time：

From 2024-09-01

To      2026-10-31

Recruiting time：

From 2024-09-01

To      2025-12-31

Interventions：

67

Group：

"Yiqi Chutan Formula" Chinese herbal formula granules (1/2 dose) group

Sample size：

Intervention：

"Yiqi Chutan Formula" Chinese herbal formula granules (1/2 dose)

Intervention code：

67

Group：

"Yiqi Chutan Formula" Chinese herbal decoction group

Sample size：

Intervention：

"Yiqi Chutan Formula" Chinese herbal decoction

Intervention code：

67

Group：

"Yiqi Chutan Formula" Chinese Medicine Granule group

Sample size：

Intervention：

"Yiqi Chutan Formula" Chinese herbal formula granules (equivalent dose)

Intervention code：

Total sample size ： 201

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Institution/hospital：

The First Affiliated Hospital of Guangzhou Medical University

Level of the institution：

Tertiary A

Country：

China

Province：

Guangdong

City：

Institution/hospital：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Guangdong

City：

Institution/hospital：

Foshan Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Guangdong

City：

Institution/hospital：

Dongguan Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Disease control rate (DCR, disease control rate) for pulmonary nodules based on the RECIST

Type：

Primary indicator

Measure time point of outcome：

Before enrollment and at 3 months after intervention

Measure method：

Chest thin-slice CT plain scan

Outcome：

Malignant risk assessment based on AI malignancy risk model

Type：

Secondary indicator

Measure time point of outcome：

Before enrollment and at 3 months after intervention

Measure method：

hest thin-slice CT plain scan and AI software analysis

Outcome：

Evaluation of Traditional Chinese Medicine (TCM) symptom efficacy (TCM constitution symptom score and TCM symptom score)

Type：

Secondary indicator

Measure time point of outcome：

Before enrollment and at 3 months after intervention

Measure method：

TCM constitution symptom score and TCM symptom score scale

Outcome：

Satisfaction score

Type：

Secondary indicator

Measure time point of outcome：

Enrollment and at 3 months after intervention

Measure method：

Satisfaction NRS (Numerical Rating Scale) score sheet

Collecting sample(s)
from participants：

Sample Name：

Venous blood

Tissue：

none

Fate of sample 

Destruction after use

Note：

Sent to the lab for testing; the results will be referenced and not saved separately.

Sample Name：

Urine

Tissue：

none

Fate of sample 

Destruction after use

Note：

Sent to the lab for testing; the results will be referenced and not saved separately.

Not yet recruiting

18
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study employs a central randomization system (IRWS) for stratified block randomization. Stratification factors include: gender and smoking status. The block length is set to 4. Using allocation concealment, subjects will be assigned in a 1:1:1 ratio to the "Yiqi Chutan Formula" decoction group, "Yiqi Chutan Formula" granules (1/2 dose) group, and "Yiqi Chutan Formula" granules (equivalent dose) group.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Data will be made public by publishing papers after the trial is completed.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

[Data Storage and Entry] All subject data and scale information will be entered into a computer by management team members or filled out by patients themselves on the WeChat scientific research follow-up platform. All original data will be entered and stored in the project database, ensuring that the entered content is consistent with the original materials. Paper documents will be managed by designated personnel. [Data Quality Control and Backup] Project team members will regularly perform quality control on the entered data, promptly report and record missing data items, and re-check and calibrate obviously erroneous data. Data will be regularly exported and backed up to physical storage devices, which will be kept by designated personnel to prevent database damage. [Quality Control] The entire project will implement quality assurance and monitoring from multiple aspects, including the quality monitoring of Traditional Chinese Medicine intervention measures, project implementation, data quality, and data analysis. This will be done through the use of network technology platforms and other means. The entire process will be subject to regular review by the ethics committee.

Data Managemen Committee：

No

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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