Clinical study of Promotes qi and removes phlegm optimization formula to prevent the progression of high-risk pulmonary nodules

Clinical study of Promotes qi and removes phlegm optimization formula to prevent the progression of high-risk pulmonary nodules - Clinical study of Promotes qi and removes phlegm optimization formula to prevent the progression of high-risk pulmonary nodules

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300069570

Enrollment

Unknown

Registered

2023-03-21

Start date

2023-04-01

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary nodules

Interventions

Experimental group:Promotes qi and removes phlegm optimization formula

Control group:Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) 18-80 years old, gender is not limited; (2) =8mm mixed ground-glass lung nodules, single or multiple (the largest lesion in multiple pulmonary nodules =8mm) (3) The subject had no functional impairment of major organs, and the blood routine, liver, kidney and heart functions were normal (4) The patient signs the informed consent form and voluntarily receives treatment and follow-up.

Exclusion criteria

Exclusion criteria: (1) Malignant tumors have not reached clinical cure and still need adjuvant therapy or palliative care; (2) Patients with combined immune diseases, such as AIDS and systemic lupus erythematosus; (3) Acute respiratory diseases or lung diseases that interfere with diagnosis, such as acute pneumonia, acute bronchitis, silicosis, tuberculosis, etc.; (4) Those with serious primary heart, liver, kidney, blood or serious diseases that affect their survival; (5) Major depression, mania, obsessive-compulsive disorder, or schizophrenia and other mental illnesses; (6) Those who are allergic to the ingredients of this traditional Chinese medicine; (7) Patients who have participated in clinical trials of other drugs in the past three months or are participating in clinical trials of other drugs; (8) Pregnant and lactating patients, women of childbearing age who have a birth plan in the past year.

Design outcomes

Primary

Measure	Time frame
2-year rate of lung nodule progression;	—

Secondary

Measure	Time frame
Lung cancer detection rate;Treatment of pulmonary nodules is effective;AI malignancy risk index;Lung nodules are the longest diameter;TCM symptom scale;Anxiety and depression scale;Pittsburgh Sleep Quality Index;Rate of progression of pulmonary nodules before/after surgery;Pulmonary nodules are effective preoperative/postoperative;	—

Countries

China

Contacts

Public ContactLin Lizhu

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

13501505588@139.com+86 13501505588

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026