Effectiveness and safety of Yifei Sanjie Granule in people with Pulmonary Mixed Nodules: A prospective controlled study

Not Applicable

• Conditions: Pulmonary Mixed Nodules

• Registration Number: ITMCTR2200006146
• Lead Sponsor: The Third Affiliated Hospital of Henan University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Patients with pulmonary mixed nodules diagnosed by thin slice (thickness of 1mm) spiral CT scan of the chest; (2) Patients with TCM evidence diagnosed as Lung qi deficiency pattern, qi deficiency of Lung Spleen qi deficiency pattern, Phlegm dampness accumulating in the lung pattern, or blood stasis evidence; (3) Age between 18 and 80 years; (4) Good communication and understanding ability; (5) With the informed consent signed.

Exclusion Criteria

(1) Patients with mixed pulmonary nodules with a maximum diameter of =10 mm in the transverse axis of the nodules in the lung window and/or a maximum diameter of =6 mm in the transverse axis of the solid component of the nodules in the mediastinal window; (2) Patients with mixed pulmonary nodules with malignant signs on imaging and recommended for biopsy or surgery after multidisciplinary consultation; (3) Considered as a metastatic pulmonary nodule; (4) Diffuse pulmonary interstitial lesions, such as interstitial pneumonia, pulmonary interstitial fibrosis, etc; (5) Patients with organ failure caused by various systemic diseases; (6) Pregnant or breast-feeding women.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The growth rate of nodule;The volume doubling time;

Secondary Outcome Measures

Name	Time	Method
Mediastinal window nodal solid component volume;Mean CT values in the transverse axial plane of the nodule;Maximum diameter of the solid component in the transverse axis of the mediastinal window node;The largest diameter in the transaxial plane of the nodule;Nodule volume;