ITMCTR2200006636尚未招募4 期
To evaluate the efficacy and safety of Bailui Granule in the treatment of acute bronchitis (lung syndrome caused by wind and heat)
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •(1) In line with the diagnosis of acute tracheo-bronchitis in Western medicine;
- •(2) The syndrome differentiation of traditional Chinese medicine is the syndrome of wind and heat invading lung;
- •(3) Onset of acute tracheo-bronchitis (onset time of cough during the course of the disease) =3 days;
- •(4) daytime cough symptom score =2 points or nighttime cough symptom score =2 points;
- •(5) Age 18-65 (including 18 and 65), both genders;
- •(6) Voluntary participation in the clinical trial, informed consent and signed the informed consent form.
排除标准
- •(1) Armpit temperature =38.5? during the course of the disease;
- •(2) Pneumonia, bronchiectasis, bronchial asthma, cough variant asthma, lung cancer, acute exacerbation of chronic obstructive pulmonary disease and other diseases accompanied with cough, sputum production symptoms or ACEI drug-induced cough;
- •(3) white blood cell count > 11×109/L or neutrophil percentage > 80%;
- •(4) During the course of the disease, before the treatment, the use of antitussive and phlegm-reducing drugs, traditional Chinese medicine decoction, acupuncture and other drugs or non-drug treatment for the disease; Antibiotics were used within 48 hours before treatment;
- •(5) Liver function ALT and AST exceeded the upper limit of the normal reference value 1.5 times or Scr exceeded the upper limit of the normal reference value;
- •(6) Complicated with serious diseases of major organs or systems such as heart, brain, liver, kidney, respiratory system and blood system, such as acute myocardial infarction, acute cerebral infarction, viral hepatitis and hemophilia;
- •(7) Allergic constitution, if there is a history of allergy to two or more drugs or food, or allergic to test drugs (including positive drugs) or their ingredients and excipients;
- •(8) women who are pregnant or planning to become pregnant, breastfeeding women, patients of reproductive age who are unable or unwilling to use adequate contraception during the trial period, or their spouses who are unwilling to use contraception;
- •(9) Suspected or confirmed history of alcohol dependence or drug abuse;
- •(10) having an intellectual or mental handicap;
- •(11) Participated in or is participating in clinical trials of other drugs or medical devices within one month;
- •(12) According to the judgment of the investigator, there are other lesions or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the work environment and unstable living environment, which are likely to cause loss of follow-up.
研究者
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