Pulmonary nodules
Conditions
Interventions
Lung cancer postoperative patients treated with syndrome differentiation granules: Syndrome differentiation granules were taken orally, 1 dose per day, divided into 2 times
Pulmonary nodules treated with Shuangshen granules group:Shuangshen granules were taken orally, 6g each time, twice a day
Lung cancer postoperative patients treated with Shuangshen granules group:Shuangshen granules were taken orally, 6g each time, twice a day
Pulmonary nodules treated with syndrome differentiation granules:Syndrome differentiation granules were taken orally, 1 dose per day, divided into 2 times
Healthy people group:No drug intervention, only 2ml of blood, tongue sample, throat swab and 3ml of stool sample were collected after enrollment for flora and tumor-related markers.
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Lung nodule inclusion criteria (1) Patients with Qi deficiency and blood stasis evidence combined with the following inclusion criteria. (2) Pulmonary nodules pathologically diagnosed as precancerous lesions such as pulmonary atypical adenomatous hyperplasia, angiogenic squamous epithelial atypia, or carcinoma in situ. (3) Solid nodules, or sub-solid nodules with no significant change at 3-month follow-up. (4) Nodules = 8 mm in size or those who have been closely followed up by a multidisciplinary team. (5) Basic normal function of heart, liver, kidney and hematopoietic system. (6) Age 18 to 75. (7) Karnofsky score = 90. (8) Voluntary participation in this study and signed informed consent form. Inclusion criteria for postoperative patients with non-small cell lung cancer (1) Patients with Qi deficiency and blood stasis evidence combined with the following inclusion criteria. (2) Those with stage I-IIIB non-small cell lung cancer who are 1 month postoperative after conventional radiotherapy. (3) Patients with higher ctDNA level than normal population by NGS test. (4) Those diagnosed by pathology as squamous lung cancer or adenocarcinoma of the lung. (5) Basic normal function of heart, liver, kidney and hematopoietic system. (6) Age 18 to 75 years old. (7) Karnofsky score = 90. (8) Voluntary participation in this study and signed informed consent form. Inclusion criteria for healthy population screening: (1) Age: 18-75; (2) In accordance with the above diagnostic criteria of healthy people, the TCM constitution is determined as peaceful quality; (3) BMI of 18-24kg/m2; (4) There is no abnormality in the physical examination.
Exclusion criteria
Exclusion criteria: Exclusion criteria: (1) Those who have other gene mutations and need targeted therapy; (2) complicated with other lung diseases (such as hypertension, diabetes, coronary heart disease, chronic obstructive pulmonary disease, asthma, interstitial lung disease, tuberculosis, etc.) and requiring long-term drug use; (3) Patients with other primary tumors outside the lungs; (4) Patients with autoimmune diseases; (5) Long-term use of hormones, anti-inflammatory drugs and immunosuppressants due to disease; (6) Alcoholics; (7) pregnant, trying to get pregnant, breast-feeding or mentally ill; (8) People who are allergic to Chinese medicine ingredients or cannot take Chinese medicine orally; (9) Patients who participated in clinical studies of other drugs or are participating in other clinical studies within 1 month prior to participating in this study; (10) Take other drugs or health food that may affect the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival,DFS;Target nodule morphology;Target nodule size;Target nodule density; | — |
Secondary
| Measure | Time frame |
|---|---|
| living quality;Anxiety evaluation;Evaluation of depression;Evaluation of TCM syndrome; | — |
Countries
China
Contacts
Public ContactLIU RUI
Outcome results
None listed