Pulmonary nodule
Conditions
Interventions
Test group:Yifei Qinghua Ointment
Control group:Test group
Sponsors
Tianjin Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects confirmed with pulmonary nodules (maximum diameter =5 mm and =3 cm) by clinical imaging examinations; 2.Subjects diagnosed with Qi deficiency syndrome via TCM syndrome differentiation or identified as Qi deficiency constitution through TCM constitution assessment; 3.Subjects who are judged by physicians to require no immediate surgical treatment, or who refuse to receive surgical treatment; 4.Aged 18 to 75 years old, with no restriction on gender; 5.Voluntary participation, possessing good communication and comprehension skills, and willing to cooperate with follow-up visits; 6.Subjects who have signed the informed consent form for this study.
Exclusion criteria
Exclusion criteria: 1. Patients suspected of metastatic pulmonary nodules; 2. Patients with pulmonary nodules caused by known benign etiologies (e.g., active infection, tuberculosis, mycosis) requiring immediate targeted etiological treatment; 3. Patients whose pulmonary nodules are deemed to require immediate surgery via multidisciplinary consultation by physicians, or those who have undergone pulmonary resection; 4. Patients complicated with other poorly controlled respiratory diseases (e.g., acute exacerbation of chronic obstructive pulmonary disease, acute exacerbation of bronchiectasis, community-acquired pneumonia, active pulmonary tuberculosis, etc.); 5. Patients with a history of lung cancer or other malignant tumors within the past 5 years; 6. Patients who have received anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy), immunomodulators within the past 3 months, or those who have taken traditional Chinese medicine or Western anti-inflammatory drugs for pulmonary nodules for more than 4 weeks prior to enrollment; 7. Patients complicated with severe primary diseases involving the heart, brain, liver, kidney, endocrine system, hematopoietic system, etc. (e.g., patients with NYHA cardiac function class III-IV, liver cirrhosis, uremia), or immunodeficiency diseases (e.g., HIV/AIDS); 8. Patients with ALT and AST levels more than 2 times the upper limit of normal, or serum creatinine (Cr) level more than 1.5 times the upper limit of normal; 9. Patients with psychiatric disorders or cognitive impairment that affect treatment compliance; 10. Pregnant women, lactating women, or women planning to become pregnant; 11. Patients with allergies or contraindications to the ingredients of Yifei Qinghua Ointment; 12. Patients who have participated in other clinical trials within the past 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the progression probability of pulmonary nodules during the trial;Changes in the Malignancy Probability of Pulmonary Nodules During the Trial; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the volume of pulmonary nodules after treatment;Changes in the maximum diameter of pulmonary nodules after treatment;Changes in the number of pulmonary nodules after treatment;Surgical treatment rate of subjects within 52 weeks; | — |
Countries
China
Contacts
Public ContactSun Daqiang
Tianjin Chest Hospital
Outcome results
None listed