Pulmonary nodule
Conditions
Interventions
Traditional Chinese Medicine treatment group:Take the Yifei Sanjie Formula
Follow-up observation group:Follow up
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the integrated Chinese- and Western-medicine diagnostic criteria for pulmonary nodules: 1)Western-medicine criterion: Per the 2024 Chinese Expert Consensus on Pulmonary Nodules, a nodule is defined as a focal, roughly round opacity =3 cm in greatest diameter that appears solid or subsolid and denser than normal lung parenchyma on imaging; it may be single or multiple and is not accompanied by atelectasis, hilar lymph-node enlargement, or pleural effusion. Solitary pulmonary nodules are usually asymptomatic, well-circumscribed, of increased density, =3 cm, and surrounded by aerated lung. 2)Traditional-Chinese-medicine (TCM) criterion: No national TCM guideline currently exists for pulmonary nodules. Therefore, any patient whose imaging meets the above nodule characteristics and in whom other lung diseases (e.g., tuberculosis, wind-warm lung-heat disease) have been excluded, and whose TCM pattern is identified as "qi & yin deficiency," will be considered for enrollment. (2) TCM pattern of qi & yin deficiency: Main signs: irritability, fatigue. Secondary signs: dry cough with little sputum, dry mouth/throat, dizziness/tinnitus, night sweats, low-grade fever, weight loss, bone-steaming fever, nocturnal emission/premature ejaculation (men), scanty or absent menses (women); red tongue with little or no coating; thin rapid pulse. (3) Age 18–80 years. (4) Willing to sign informed consent, able to answer questions truthfully, and committed to follow-up visits.
Exclusion criteria
Exclusion criteria: (1) Patients with confirmed pulmonary tuberculosis or other infectious diseases; (2) Patients with severe primary diseases of the heart, brain, liver, kidneys, or blood system, or with concurrent malignancies; (3) Patients with psychiatric disorders such as mania or schizophrenia, or who are otherwise unable to comply with study requirements; (4) Pregnant or lactating women; (5) Patients with known allergy to any Chinese herbal medicine used in this study, or with a history of allergies to multiple drugs; (6) Patients who have participated in another pulmonary-nodule clinical trial within the past month, or who had an upper-respiratory infection or took antibiotics within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum diameter of the largest pulmonary nodule; | — |
Secondary
| Measure | Time frame |
|---|---|
| Location of the largest pulmonary nodule;Number of pulmonary nodules;Density of the largest pulmonary nodule;Malignancy probability of pulmonary nodules;Traditional Chinese Medicine syndrome score;Quality-of-life questionnaire (QLQ-LC43); | — |
Countries
China
Contacts
Public ContactWU JianChun
Shanghai Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed