To evaluate the efficacy, safety and pharmacoeconomics of Shiwei Longdanhua capsule in the treatment of acute tracheo-bronchitis (phlegm-heat obstructing lung syndrome)

The Second Affiliated Hospital of Tianjin University of Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年3月6日

适应症

试验速览

暂无简介。

•To be eligible for the trial, subjects must meet all of the following criteria:
•(1) Meet the diagnostic criteria of acute tracheobronchitis in western medicine;
•(2) Consistent with the syndrome differentiation criteria of phlegm-heat obstructing the lung;
•(3) Cough score =4 at screening;
•(4) The course of disease at screening =72 hours;
•(5) Age of 18-70 years old (including 18 and 70 years old), regardless of gender;
•(6) Able to understand the purpose and risks of the trial, abide by the trial procedures, and sign the informed consent.

•Subjects who met any of the following criteria were excluded from the trial.
•(1) Body temperature =37.3? at screening;
•(2) White blood cell count and/or neutrophil count at screening = 1.2 times the upper limit of normal value (ULN);
•(3) AST, ALT= 1.5 times upper limit of normal value (ULN), SCr= 1.5 times upper limit of normal value (ULN);
•(4) Patients who had taken other drugs for the treatment of the disease (such as antibiotics, expectorants, antitussive drugs, hormones or traditional Chinese medicine for relieving cough, resolving phlegm and asthma) within 24 hours before drug administration;
•(5) Combined with pulmonary infection, tuberculosis, lung cancer, bronchopneumonia, chronic obstructive pulmonary disease, bronchial asthma or other pulmonary diseases;
•(6) Patients with serious cardiovascular, hepatic, renal, or hematopoietic diseases who were judged by the investigators to be unsuitable for enrollment;
•(7) Pregnant or preparing to become pregnant or lactating women;
•(8) Patients suffering from mental illness or unable to cooperate with treatment;
•(9) Allergic constitution (allergic to more than two kinds of substances), or allergic to the test drug and its components;
•(10) Have participated in or are participating in other drug clinical trials within the past 1 month;
•(11) Suspected or real history of alcohol or drug abuse, or according to the investigator's judgment, not suitable for enrollment.

发起方

The Second Affiliated Hospital of Tianjin University of Chinese Medicine