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A Single-arm Clinical Study on the Intervention of Shuanghuangsanjie Formula Combined with Tianwuxiaoliu Tablets in Early Pulmonary Ground Glass Nodules

A Single-arm Clinical Study on the Intervention of Shuanghuangsanjie Formula Combined with Tianwuxiaoliu Tablets in Early Pulmonary Ground Glass Nodules

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073825
Enrollment
Unknown
Registered
2023-07-21
Start date
2023-07-24
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Pulmonary Ground-Glass Nodule

Interventions

Treatment group:All patients in the group were given Shuanghuangsanjie Formula and Tianwuxiaoliu Tablets.

Sponsors

Yue Yang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age = 18 years; 2)Patients with first or previous 2 year chest CT findings of intra-pulmonary ground glass nodules: single or multiple and maximum nodule diameter = 5mm and =8mm; or nodules >8mm in diameter but not requiring surgery or unwilling to have surgery. 3) Bone marrow function (white blood cell count, haemoglobin, platelet count, etc.), liver function (glutamate transaminase, glutamic oxalacetic transaminase, total/direct/indirect bilirubin, bile acids) and renal function (urea, creatinine, uric acid) are within normal limits. 4) Able to understand and willing to sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with other malignant diseases 2)Those with combined severe diabetes, cardiovascular disease, liver or kidney insufficiency; or those with other severe chronic diseases and unable to care for themselves; 3) Pregnant or lactating women, or women who plan to become pregnant during the study period. Non-menopausal women will be required to have a urine pregnancy test added to the baseline examination; 4) Patients suffering from moderate or higher levels of depression and anxiety, as well as those with a history of mental illness or disorders of consciousness; 5)Patients who have participated in clinical trials of other drugs in the last three months or are participating in clinical trials of other drugs; 6)Those who are allergic to the ingredients of traditional Chinese medicine and proprietary Chinese medicine in this study.

Design outcomes

Primary

MeasureTime frame
Nodule stability rate;

Secondary

MeasureTime frame
Non-targeted metabolomics analysis;Anxiety and depression assessment;

Countries

China

Contacts

Public ContactYabin Gong

Yue Yang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai University of Traditional Chinese Medicine

gongyabin@shutcm.edu.cn+86 18923873

Outcome results

None listed

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