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Comparison of therapeutic effects of brucea brucea oil emulsion injection and cisplatin injection in the treatment of malignant pleural effusion

Comparison of therapeutic effects of brucea brucea oil emulsion injection and cisplatin injection in the treatment of malignant pleural effusion

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047969
Enrollment
Unknown
Registered
2021-06-28
Start date
2021-06-20
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

Malignant pleural effusion

Interventions

Experimental group:Bruisea oil emulsion injection
Control group:Cisplatin monotherapy

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with solid malignant tumors confirmed by cell or histopathology; 2. The pathological diagnosis of pleural effusion is malignant pleural effusion; 3. There is no contraindication to medical chemotherapy, and no intrapleural injection in the past month; 4. Complicated with moderate or more pleural effusion (definition of moderate pleural effusion: pleural effusion >= 3 cm in supine position B-ultrasound examination; pleural effusion >= 4 cm in sitting position B-ultrasound examination); 5. Aged 18-80 years; 6. KPS score >= 60, expected survival period > 2 months; 7. The patients have good compliance, can understand the situation of this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient is allergic to cisplatin and other platinum preparations and the test excipients or has peripheral neuropathy caused by cisplatin; 2. Combined with severe chronic obstructive pulmonary disease and/or respiratory failure; 3. There is currently an uncontrolled serious infection; 4. Large amount of bilateral pleural effusion or encapsulated effusion; 5. The patient has serious diseases such as heart, liver, kidney and hematopoietic system; 6. Patients with a history of mental illness that is not easy to control; 7. Patients who are pregnant or breastfeeding; 8. Patients who underwent radiotherapy and local therapy in the past month.

Design outcomes

Primary

MeasureTime frame
Volume of pleural effusion;

Countries

China

Contacts

Public ContactGong Yabin

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

gongyabin@hotmail.cmo+86 13818269929

Outcome results

None listed

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