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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006146
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Pulmonary Mixed Nodules

Interventions

control group:Simple follow-up
experimental group:Yifei sanjie granule

Sponsors

The Third Affiliated Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The growth rate of nodule;The volume doubling time;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactLi Jiansheng
li_js8@163.com+86 371 66248624

Outcome results

None listed

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