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A multicenter, controlled, prospective clinical study exploring the use of Xihuang Wan for early intervention of pure ground glass pulmonary nodules

A multicenter, controlled, prospective clinical study exploring the use of Xihuang Wan for early intervention of pure ground glass pulmonary nodules

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100372
Enrollment
Unknown
Registered
2025-04-08
Start date
2023-11-15
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Pure ground glass pulmonary nodules

Interventions

Experimental group:Xihuang Wan, Oral
Control group:None

Sponsors

Tianjin Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.18 years <= Age <= 75 years; 2. Patients with pulmonary nodules who have been confirmed by chest CT to meet all of the following conditions: (1) Pure ground glass nodules; (2) The longest diameter is 6-20 mm; (3) When there are multiple nodules, at least one nodule meets the above requirements; 3. Clinical doctors believe that patients are not recommended for surgery at the moment and may consider follow-up observation; 4. The ECOG score is 0-1 points; 5. Voluntarily participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known to be allergic to the components of Xihuang Wan, or to avoid or use Xihuang Wan with caution (experimental group); 2. Try to treat pure ground glass nodules within the previous month or during the study period: such as anti-inflammatory treatment, traditional Chinese patent medicines, anti tuberculosis treatment, anti-tumor treatment, etc; 3. A history of malignant tumors within 5 years; 4. Pregnant or lactating women or women who do not agree to contraception; 5. Patients with a history of mental illness who are unable to cooperate with this project.

Design outcomes

Primary

MeasureTime frame
Total response rate at 6 month;

Secondary

MeasureTime frame
Longest diameters of target nodules;Density of target nodules;The proportion of patients with solid components;Treatment-emergement adverse events;

Countries

China

Contacts

Public ContactDaqiang Sun

Tianjin Chest Hospital

sdqmd@163.com+86 180 0209 3188

Outcome results

None listed

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