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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000257
Enrollment
Unknown
Registered
2024-08-19
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary nodule

Interventions

"Yiqi Chutan Formula" Chinese herbal formula granules (1/2 dose) group:"Yiqi Chutan Formula" Chinese herbal formula granules (1/2 dose)
"Yiqi Chutan Formula" Chinese Medicine Granule group:"Yiqi Chutan Formula" Chinese herbal formula granules (equivalent dose)
"Yiqi Chutan Formula" Chinese herbal decoction group:"Yiqi Chutan Formula" Chinese herbal decoction

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Malignant risk assessment based on AI malignancy risk model;Evaluation of Traditional Chinese Medicine (TCM) symptom efficacy (TCM constitution symptom score and TCM symptom score);Satisfaction score;

Countries

China

Contacts

Public ContactLizhu Lin

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

gzucmlinlz@163.com020-36591693

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026