ITMCTR2200006634尚未招募4 期
To evaluate the efficacy and safety of Bailui Granule in the treatment of common cold (wind-heat syndrome)
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) consistent with the diagnosis of common cold in Western medicine;
- •(2) TCM syndrome differentiation is wind-heat syndrome;
- •(3) Within 48 hours from onset of illness to medical treatment;
- •(4) armpit temperature =39.0?;
- •(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) Influenza, pneumonia, COVID-19, suppurative tonsillitis, acute tracheo-bronchitis, tuberculosis, other acute nasal diseases (such as allergic rhinitis, acute and chronic rhinitis, acute and chronic rhinosinusitis, etc.), nasal mucosal dysfunction after nasal surgery or radiotherapy of the nasopharynx;
- •(2) white blood cell count > 11.0×109/L or neutrophil percentage > 80%;
- •(3) During the course of the disease, before seeing the doctor, take other drugs for the disease such as cold medicine, antiviral drugs, antibiotics, traditional Chinese medicine and other drugs;
- •(4) 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;
- •(5) 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;
- •(6) Allergic constitution, if there is a history of allergy to two or more drugs or food, or allergic to test drugs (including positive drugs and emergency drugs) or their ingredients and excipients;
- •(7) 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;
- •(8) Suspected or confirmed history of alcohol dependence or drug abuse;
- •(9) having an intellectual or mental handicap;
- •(10) Participating in or currently participating in clinical trials of other drugs or medical devices within one month;
- •(11) 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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