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Clinical study on the prevention of acute radiation pneumonia by Shabairunfei formula

Clinical study on the prevention of acute radiation pneumonia by Shabairunfei formula

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072148
Enrollment
Unknown
Registered
2023-06-05
Start date
2023-06-06
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Acute radiation pneumonitis

Interventions

Control group:No
Experimental group:Oral Shabairunfei formula for 60 days

Sponsors

Shanxi Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Patients over 18 years of age who will receive radiotherapy for tumors with an irradiation field that includes the lungs, regardless of gender (2) KPS score = 60 (3) Expected survival = 3 months (4) Expected to receive = 60 days of trial drug treatment (5) Radiotherapy plan with a total dose of 8Gy or more to the lungs (6) No infection before radiotherapy (7) The patient agrees to participate in this trial and has signed an informed consent form

Exclusion criteria

Exclusion criteria: (1) Those who fast or oppose taking the test drug (2) Combination of serious non-neoplastic cardiac or pulmonary primary diseases, such as acute exacerbation of chronic bronchitis, pulmonary heart disease, pulmonary embolism, FEV1/FVC <70%, and FEV1 <50% (predicted), or other serious diseases, such as bronchial fistula (3) Brain metastases or other diseases that cause mental impairment of consciousness and inability to cooperate (4) Pregnant or lactating women (5) Allergy and allergy to the test drug or control placebo (6) Previously treated with chest radiotherapy (7) White blood cell <4.0×10^9/L or hemoglobin <80g/L before treatment

Design outcomes

Primary

MeasureTime frame
Incident of acute radiation pneumonitis;Acute radiation lung injury RTOG classification;

Secondary

MeasureTime frame
TCM susceptibility points;KPS score;Serum specific index of IL-6 IL-8 TNF-a;

Countries

China

Contacts

Public ContactDing Hao

Shanxi Chinese Medicine Hospital

quzequandh@126.com+86 188 1055 0731

Outcome results

None listed

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