A randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of Huaban Decoction combined with ShenlingBaizhu Powder in the prevention of radiation lung injury in patients with lung cancer radiation therapy

A randomized controlled clinical study on the prevention of radiation-induced lung injury by Huaban Decoction combined with ShenlingBaizhu Powder in lung cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078084

Enrollment

Unknown

Registered

2023-11-28

Start date

2023-12-01

Completion date

Unknown

Last updated

2023-12-03

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

Conditions

lung cancer

Interventions

experimental group:Huaban Decoction combined with ShenlingBaizhu Powder

controlled group:Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Advanced non-small cell lung cancer confirmed by pathology is not suitable for surgery or the patient refuses surgical treatment and receives radiotherapy; 2. Meet the diagnostic criteria of TCM syndrome differentiation; 3. Age 18-75 years old; 4. Expected survival =6 months; 5. ECOG 0-2 points; 6. Have sufficient main organ functions: hemoglobin =100g/L, platelets =90×10^9/L, neutrophils =1.5×10^9/L; serum creatinine SCR<1.5 ULN; ALT and AST < 1.5 ULN, bilirubin < 1.5×ULN; 7. No history of drug allergy; 8. Voluntarily participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with previous or concurrent malignant tumors; 2. Previous chest radiation therapy; 3. Congenital or acquired immune deficiency; 4. Hiv-positive, including having received antiretroviral therapy; Chronic hepatitis B, viral replication stage; Hepatitis C active phase; 5. Pregnancy (confirmed by serum or urine ß-HCG test) or lactation; 6. The patient's overall health was poor, with KPS 2; 7. Patients with a history of uncontrollable mental illness; 8. The patient has conditions that the researchers believe may increase the risk of treatment or has serious uncontrollable complications; 9. Patients who have taken TCM preparations within 14 days; 10. Participants who have participated or are participating in other clinical trials within the last three months.

Design outcomes

Primary

Measure	Time frame
acute radiation-induced lung injury;	—

Secondary

Measure	Time frame
objective response rate;quality of life;Traditional Chinese Medicine Syndrome Points;Pulmonary function indicators;Any adverse events related to drug therapy at level 2 or above;	—

Countries

China

Contacts

Public ContactWang Lei

Longhua Hospital Shanghai University of Traditional Chinese Medicine

wangl9109@163.com+86 21 6438 5700

Outcome results

None listed

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