Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT05525260
Eligibility Criteria:
Inclusion Criteria:
* Non-smokers (those who have smoked less than 100 cigarettes in their lifetime, including those who have never smoked in their lifetime).
* Subjects must have positive nodules detected by high-resolution CT（HRCT）: longest diameter \> 6 mm and \< 20 mm; pure ground glass nodule; according to the judgment of the clinician, follow-up can be performed, and surgical excision is not recommended for the time being; the nodules did not disappear or were not significantly reduced by more than 2 mm after six months follow-up; subjects should have at least one positive nodule when had multiple nodules.
* ECOG performance status 0-1.
* Those who accept and are willing to sign the informed consent.
Exclusion Criteria:
* Subjects with the history of autoimmune diseases and severe gastrointestinal diseases;
* Subjects suffering from malignant tumor, severe heart disease, severe liver or kidney disease currently or within the past 5 years;
* Within 6 weeks since prior herbal supplements, non-steroidal anti-inflammatory drugs, or antibiotics
* Subjects who are allergic to limonene capsules or citrus foods;
* Use of any other investigational agents at time of enrollment in the study during the three months preceding study enrollment
* Pregnant or lactating females, or those who disagreeing with contraception;
* Subjects who have a history of mental illness and cannot cooperate with this project;
* HIV-positive subjects should be excluded.
* Subjects whose organ and bone marrow function indexes exceeded the following range of normal value were excluded:
1. Leukocytes: 3.5-9.5 109/L;
2. Absolute neutrophil count: 1.8-6.3 109/L;
3. Platelets: 125-350 109/L;
4. Total bilirubin: 5.0-21.0 µmol /L;
5. AST (SGOT)/ALT (SGPT): 0.8-1.5;
6. Serum creatinine: 41-81 μmol/L;
* Other situations where the researcher thinks it is inappropriate to participate in this research.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT05525260
Study Brief:
Protocol Section:
NCT05525260