pulmonary nodule
Conditions
Interventions
experimental group:Qingfei Sanjie granule
control group:Qingfei Sanjie placebo
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: ?Meets the Western medical diagnostic criteria for pulmonary nodules, and the Lung RADs grading of pulmonary nodules is classified as Class 2 and Class 3 ?Chest CT reveals pulmonary nodules, which have remained stable without significant growth or disappearance in the past three months ?Traditional Chinese Medicine syndrome differentiation belongs to the syndrome of Qi deficiency, dampness and heat stagnation ?Age between 18 and 85 years old, regardless of gender ?Voluntary participation, good communication and understanding skills, and willingness to cooperate with others ?All patients participating in this study should sign the informed consent forms
Exclusion criteria
Exclusion criteria: ?Evaluated as a high-risk nodule, classified as Lung RADS grade 4 or above, with a malignancy probability greater than 5%, indicating surgical treatment, or having undergone pulmonary resection; ?Consider metastatic pulmonary nodules; ?patient complicated with other serious respiratory diseases, such as chronic obstructive pulmonary disease, bronchiectasis, community acquired pneumonia, and active tuberculosis; ?TCM syndrome differentiation of spleen and stomach weakness is manifested as one of the following three conditions: 1)epigastric distension or dull pain, stomach preference for warm, loose stools, fatigue, weak tongue, tooth marks on the side; 2)gastric epigastric fullness, aggravated by cold, noisy acid reflux, dry mouth and bitter mouth, cold limbs and loose stool; 3)loose stool when diarrhea, the diet is slightly careless that hair or aggravate, weak tongue; ?Patients who took Chinese herbal medicine, Chinese patent medicine that had the effect of clearing heat and reducing phlegm and relieving cough or had the antibacterial effect clearly defined by modern pharmacology within 48 hours before enrolled; ?Patients who have been treated with traditional Chinese medicine or Western anti-inflammatory drugs for pulmonary nodules for more than 4 weeks prior before enrolled; ?patients who have participated in or are participating in other clinical trials within the last 3 months; ?patients who are unwilling to accept observation measures or unable to cooperate due to mental illness; ?patients with severe allergic reaction, or known allergic history to Qingfei Sanjie granules or placebo ingredients; ?pregnancy, planned pregnancy or lactation women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of pulmonary nodule imaging evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Risk of Brock model malignancy in pulmonary nodules;Risk of Mayo model malignancy in pulmonary nodules;Pulmonary nodule progression rate;Changes in pulmonary nodule area;Changes in the number of pulmonary nodules;Traditional Chinese Medicine Syndrome Scoring;PSQI score;GAD-7 and PHQ-9 score;SF-36 score;Traditional Chinese Medicine Dampness Syndrome Evaluation Scale; | — |
Countries
China
Contacts
Public ContactLin lin
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed