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The Clinical Study on Delayed Growth of Pulmonary Nodules at High Risk of Lung Cancer by Yiqi Yangyin Jiedu Decotion (YQYYJD)

The Clinical Study on Delayed Growth of Pulmonary Nodules at High Risk of Lung Cancer by Yiqi Yangyin Jiedu Decotion (YQYYJD)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068321
Enrollment
Unknown
Registered
2023-02-15
Start date
2023-02-15
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Pulmonary Nodules at High Risk of Lung Cancer

Interventions

experimental group:Oral Yiqi Yangyin Jiedu Decotion (YQYYJD)
control group:none

Sponsors

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with stage I lung cancer who met the diagnostic criteria of primary lung cancer and were confirmed by histopathology or cytology included adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma and large cell carcinoma; (2) ground glass nodule (GGN) was found on CT scan, which indicated that it was adenocarcinoma in situ (AIS) or minimally invasive adenocarcinoma (MIA) (mainly judged by size and density), with an average diameter of > 6 Mm, generally not exceeding 12mm, or CT scan revealed clear nodules of the same type before operation, mainly with ground glass nodules (solid nodules need more strict diagnosis and exclusion); (3) syndrome differentiation of Qi and yin deficiency by TCM; (4) 6 months or more after untreated or previous inhalation of budesonide; (5) heart, liver, kidney and blood tests were all in normal range. (6) Sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with other primary malignant tumors; (2) Patients with serious heart, liver and kidney diseases and severe functional disorders; (3) Pregnant or lactating women; (4) Mental or cognitive disorders that affect the judgment of this study; (5) Those who are participating in other drug trials; (6) Those who are allergic to the drugs in this study.

Design outcomes

Primary

MeasureTime frame
GGO disease control rate;

Secondary

MeasureTime frame
Blood Cell free DNA (TP53, EGFR, PIK3CA);TAAB(p53?PGP9.5?SOX2?GAGE7?GBU4-5?CAGE?MAGE A);Tumor markers;immune function markers;quality of life (QOL);

Countries

China

Contacts

Public ContactGuangxin Ruan

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

remus761111@163.com13817650153

Outcome results

None listed

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