An Exploratory Study on the Syndrome Differentiation and Treatment Principles of Traditional Chinese Medicine for Lung Cancer Complicated with Cough and Dyspnea, and the Exploration of Efficacy-Enhancing and Toxicity-Reducing Regimens-Part two Radiotherapy Group

Authors
Category Primary study
Registry of TrialsInternational Traditional Medicine Clinical Trial Registry
Year 2025
INTERVENTION: Control Group:Radiotherapy + Placebo (Yanghe Dingchuan Plaster Placebo/Bufei Jiedu Granule Placebo)Yanghe Dingchuan Plaster Placebo: 45 g per dose, dissolved in hot water, twice daily;Bufei Jiedu Granule Placebo: 1 sachet per dose, dissolved in hot water, twice daily.;Experimental Group:Radiotherapy + Traditional Chinese Medicine (Yanghe Dingchuan Plaster/Bufei Jiedu Granule)Yanghe Dingchuan Plaster: 45 g per dose, dissolved in hot water, twice daily;Bufei Jiedu Granule: 1 sachet per dose, dissolved in hot water, twice daily.; CONDITION: Non‐small cell lung cancer PRIMARY OUTCOME: Improvement rate of traditional chinese medicine syndrome score; SECONDARY OUTCOME: Objective response rate;Progression‐free survival;Incidence of radiation pneumonitis (RP); Eastern Cooperative Oncology Group Performance Status (ECOG PS) ;Visual Analogue Scale for Assessing Cough Severity;Pulmonary function;Serum level of lymphocyte subsets and cytokines; INCLUSION CRITERIA: 1.Meet the TCM diagnostic criteria for cough and dyspnea. 2.Fulfill the NSCLC diagnostic criteria outlined in the Chinese Medical Association's Clinical Guidelines for Lung Cancer Diagnosis and Treatment (2024 Edition). 3.Aged 40 years or older. 4.With an ECOG performance status score of 0 to 2. 5. Have at least one measurable intrathoracic lesion amenable to surgery or radiotherapy. 6. Have adequate organ and bone marrow function prior to trial participation, as evidenced by laboratory results obtained within 14 days before radiotherapy meeting the following criteria: a) Absolute neutrophil count (ANC) greater than or equal to 1.5 multiplied by 10^9/L; b) Platelet count greater than or equal to 75 multiplied by 10^9/L (without transfusion within 14 days); c) Hemoglobin greater than or equal to 90 g/L; d) Total bilirubin less than or equal to 1.5 times the upper limit of normal; e) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
Epistemonikos ID: b7c9fc343ae17de4c98cffe1ac70cbe1cf14af5c
First added on: Jan 24, 2026