small pulmonary nodules
Conditions
Interventions
observation group:Oral Intervention of Qingjin Sanjie Formula for 12 Weeks
control group:According to expert consensus, follow-up observation for 12 weeks, during which no drug intervention was given.
Sponsors
Wangjing Hospital of Chinese Academy of chinese medical sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Pulmonary nodules were detected by high-resolution CT scan, which met the diagnostic criteria of small pulmonary nodules. The diameter of nodules was 5-10mm; 2) Risk assessment is high/medium risk; 3) Methylation level of SHOX2/PTGER4/RASSF1A gene>0; 4) The constitution of TCM is easy to suffer from (qi stagnation/phlegm dampness/qi deficiency/yang deficiency); 5) 18-75 years old; 6) Sign informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients requiring immediate surgical intervention after multidisciplinary consultation or requiring surgery at the request of the patient; 2) Patients with previous history of lung malignant tumor; 3) Currently diagnosed lung infection; 4) Within 1 month prior to enrollment or participating in clinical trials of other drugs; 5) Patients with a history of surgery within 3 months; 6) Patients with serious cardiovascular, cerebrovascular, liver, kidney and blood system diseases, unstable underlying diseases; 7) known adverse reactions to the intervening drug ingredients; 8. Pregnant and lactating women; 9) Patients with intellectual or language impairments who cannot fully understand the test content or give good cooperation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum SHOX2/RASSF1A/PTGER4 gene methylation levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in high-resolution CT of the chest, including nodule diameter, proportion of solid components, and risk assessment;;TCM Constitution types;Lung cancer autoantibodies 7 items;Lung nodule malignancy risk prediction score; | — |
Countries
China
Contacts
Public ContactFeng Gao
Wangjing Hospital of Chinese Academy of chinese medical sciences
Outcome results
None listed