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Clinical Research Scheme of Clinical Efficacy Evaluation of Yiqi Huatan Sanjie Decoction in the Treatment of Pulmonary Nodules

Clinical Efficacy Evaluation of Yiqi Huatan Sanjie Decoction in the Treatment of Pulmonary Nodules

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063597
Enrollment
Unknown
Registered
2022-09-13
Start date
2022-09-12
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Pulmonary nodules

Interventions

Sponsors

Beijing Hospital of TCM,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) The imaging performance shows that there is at least one measurable lung nodule, which meets the following conditions: ? The average diameter of solid component of solid nodule or part of solid nodules is =6.0mm and < 15.0mm, or the average diameter of non-solid nodules is =8.0mm and < 15.0 mm; Or ? The average diameter of solid nodules, solid components of partial solid nodules or non-solid nodules is = 15.0 mm. (2) The time for initial discovery of lung nodules is less than three months, which can provide chest CT examination results; (3) Aged 18–74 years old, no gender limitation; (4) The main syndromes in TCM are deficiency of lung and spleen, and mutual accumulation of phlegm and blood stasis. (5) Patients who complained of pulmonary nodules and required traditional Chinese medicine treatment, agreed to participate in this study and signed the informed consent form, and were able to receive the treatment and follow-up observation as planned, with good compliance.

Exclusion criteria

Exclusion criteria: (1) Patients with confirmed sarcoidosis and infectious diseases caused by known pathogens; (2) A history of previous malignant tumors, with or without the exception of recurrence or metastasis confirmed by clinical or pathological diagnosis; (3) Those who, after collective consultation by multidisciplinary physicians, were highly suspected to be malignant and suitable for surgical treatment; (4) No reexamination after anti-inflammatory treatment; (5) Patients taking glucocorticoids or other immunosuppressive agents in the past one month; (6) Patients with severe primary diseases or tumor diseases such as cardiovascular and cerebrovascular diseases, liver, kidney, and blood; (7) Accompanied with mental diseases such as mania, schizophrenia and other reasons, unable to cooperate with observation and research; (8) Planned pregnancy, pregnant or lactating women; (9) Allergies to known investigational drugs; (10) Clinical trials of other drugs are ongoing; (11) Analysis of the impact of missing case information on data.

Design outcomes

Primary

MeasureTime frame
Pulmonary nodule volume;Mean diameter of pulmonary nodules;Mean diameter of pulmonary nodules;Pulmonary nodule site;Pulmonary nodule density;Morphology of pulmonary nodules;

Secondary

MeasureTime frame
Traditional chinese medicine syndrome scoring;Mental condition;Serum tumor markers;

Countries

CHINA

Contacts

Public ContactYU Ming-wei

Beijing Hospital of TCM,Capital Medical University

yumingwei1120@163.com13810081763

Outcome results

None listed

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