Pulmonary nodule
Conditions
Interventions
TCM Treatment Group:Oral administration of TCM decoction
Blank Control Group:No treatment administered. Participants receive regular CT follow-up to observe natural progression of pulmonary nodules.
Sponsors
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) Chest CT showing a focal, round or oval, increased-density solid or subsolid pulmonary lesion with a diameter =3 cm. (2) Age =18 years, with no restriction on sex. (3) Stable vital signs, clear consciousness, no history of psychiatric disorders, no hepatic or renal dysfunction, and no severe diseases of the endocrine or hematologic systems; absence of immunodeficiency.Only patients who met all of the above criteria were eligible for inclusion. (4) Provision of informed consent, with voluntary participation in this clinical observation and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who do not meet the above diagnostic criteria of Chinese and Western medicine and/or the inclusion criteria. (2) Patients whose previous examinations suggest that the nodule is suspicious for malignancy and who are clinically advised to undergo surgical or minimally invasive intervention, or to receive antitumor-related adjuvant therapy. (3) Patients diagnosed with pulmonary tuberculosis, pulmonary fungal infection, pneumonia, or other pulmonary diseases with a definite etiology, who are currently receiving or require immediate anti-tuberculosis, antifungal, anti-infective, or other related treatments. (4) Patients with a highly allergic constitution or known allergy to the study medications. (5) Pregnant women, women preparing for pregnancy, or breastfeeding women. (6) Patients with severe metabolic disorders, cardiopulmonary insufficiency, hepatic or renal dysfunction, or those who have recently undergone major surgery or trauma. (7) Patients with psychiatric disorders or other cognitive impairments who lack the capacity for autonomous decision-making. (8) Patients who have participated in other clinical trials within the past 3 months or are currently participating in other studies. (9) Patients judged by the study investigators to have poor compliance, who are unable to take the study medication or complete follow-up examinations as required, thereby potentially affecting the evaluation of efficacy and safety, or who are likely to be lost to follow-up. Note: Patients meeting any of the above criteria were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary nodule disappearance at 3 or 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of maximum diameter >1.5 mm;Reduction of cross-sectional area >5%;Reduction in number of nodules =1;downgrading of lung nodule risk classification;Decrease in CT score;Decrease in TCM syndrome score; | — |
Countries
China
Contacts
Public ContactGezhengxing
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Outcome results
None listed