Last updated: February 2, 2023
Sponsor: Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting
Phase
2
Condition
Pulmonary Nodules
Treatment
N/AClinical Study ID
NCT05525260
DISH-pGGO
Ages 45-75 Female
Study Summary
Eligibility Criteria
Inclusion
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): longestdiameter > 6 mm and < 20 mm; pure ground glass nodule; according to the judgment ofthe clinician, follow-up can be performed, and surgical excision is not recommendedfor the time being; the nodules did not disappear or were not significantly reduced bymore than 2 mm after six months follow-up; subjects should have at least one positivenodule when had multiple nodules.
- ECOG performance status 0-1.
- Those who accept and are willing to sign the informed consent.
Exclusion
Exclusion Criteria:
- Subjects with the history of autoimmune diseases and severe gastrointestinal diseases;
- Subjects suffering from malignant tumor, severe heart disease, severe liver or kidneydisease 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 thethree 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 ofnormal value were excluded:
- Leukocytes: 3.5-9.5 109/L;
- Absolute neutrophil count: 1.8-6.3 109/L;
- Platelets: 125-350 109/L;
- Total bilirubin: 5.0-21.0 µmol /L;
- AST (SGOT)/ALT (SGPT): 0.8-1.5;
- Serum creatinine: 41-81 μmol/L;
- Other situations where the researcher thinks it is inappropriate to participate inthis research.
Study Design
Total Participants: 160
Study Start date:
February 01, 2023
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Shanghai Chest Hospital
Shanghai, Shanghai 200030
ChinaActive - Recruiting
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