Pulmonary nodule
Conditions
Interventions
Experimental Group:Oral Guang Yao Ganoderma Spore Oil Soft Capsules
Sponsors
Guangzhou Medical University First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-80 years (inclusive of boundary values), gender; (2) Meet the diagnostic criteria for pulmonary nodules; (3) At screening, chest CT confirms that the target lesion meets the following conditions: 1) 5mm < long diameter = 15mm 2) Solid nodule, clinically assessed as benign. Note: If multiple nodules are present, the one with the longest diameter is selected as the target lesion. If multiple nodules have the same maximum long diameter, the investigator selects one as the target lesion. (4) Agree to participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Conditions with the following impact evaluations, including but not limited to tuberculosis, pneumonia, lung abscess, rib fractures, pulmonary infarction, etc. (2) Solid nodules with malignant or hamartoma signs. (3) Positive T-SPOT test results. (4) Pulmonary nodules that have increased in diameter compared to the previous CT scan and have a doubling time consistent with tumor growth patterns. (5) Positive results for any of the following lung tumor markers: Pro-Gastrin-Releasing Peptide (Pro-GRP), Neurospecific Enolase (NSE), Carcinoembryonic Antigen (CEA), Cytokeratin Fragment 19 (CYFRA21-1), or Squamous Cell Carcinoma Antigen (SCC). (6) Indeterminate pulmonary nodules determined through multidisciplinary team mode and shared decision-making with the patient. (7) More than 10 diffuse pulmonary nodules. (8) CT reports indicating pulmonary calcified nodules, pleural nodules, pleural plaques, or pleural calcified nodules, and deemed clinically significant by the investigator. (9) Non-invasive or invasive tests suggesting a high likelihood of malignancy in pulmonary nodules or Lung-RADS category 4 or higher, with surgical treatment recommended. (10) Known or suspected allergy to components of the investigational product or having an allergic constitution. (11) Currently using or expected to require concomitant use of the following products or treatments during the trial that may impact trial evaluations, including but not limited to: radiotherapy, radiofrequency ablation, surgical resection, etc. (12) ALT, AST = 1.5 times the upper limit of normal, SCr > upper limit of normal. (13) Patients with severe primary diseases and functional impairments of the heart, brain, liver, kidneys, hematopoietic system, or endocrine system. (14) Patients with neurological or psychiatric disorders who are unable or unwilling to cooperate. (15) Pregnant women, breastfeeding women, or those with plans for pregnancy in the near future. (16) Participation in other interventional clinical trials within the past 3 months. (17) Investigators determine that the participant is unable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of disappearance and reduction in lung nodules observed after 180 days of administration, as assessed by imaging.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the number of nodules from baseline after 90 and 180 days of administration.;The change in malignancy risk score (Mayo model) from baseline after 90 and 180 days of administration.;The change in target lesion volume from baseline after 90 and 180 days of administration.;The changes in Lung-RADS grade of the target nodule compared to baseline after 90 and 180 days of administration (the proportions of grade increases, decreases, and no change).;The changes in AI diagnostic system analysis results for target lesions after 90 and 180 days of administration compared to baseline.;The improvement rate in imaging evaluation of pulmonary nodules after 90-day administration.; | — |
Countries
China
Contacts
Public ContactLiang Wenhua
Guangzhou Medical University First Affiliated Hospital
Outcome results
None listed