ITMCTR2200006021尚未招募4 期
Randomized, double-blind, positive drug parallel control, multi-center Chinese medicine variety protection clinical trial on the efficacy and safety of Baihe Gujin tablet in the treatment of post-cold cough (lung-kidney yin deficiency syndrome).
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •(1) Meet the diagnostic criteria for post-cold cough in the Guidelines for Diagnosis and Treatment of Cough (2015);
- •(2) Comply with the standard of TCM syndrome differentiation of lung and kidney yin deficiency;
- •(3) When visiting a doctor, the daytime or nighttime cough score is =2 points, and the cough VAS score is more than 3 points;
- •(4) Aged 18 to 65 years old (including 18 and 65 years old), gender is not limited;
- •(5) Subjects gave informed consent, voluntarily tested and signed the informed consent form.
排除标准
- •(1) Cough variant asthma (CVA), upper airway cough syndrome (UACS), eosinophilic bronchitis (EB), gastroesophageal reflux cough (GERC), chronic bronchitis, chronic obstructive pulmonary disease Patients with subacute or chronic cough caused by diseases and other causes;
- •(2) ALT and/or AST >1.5 upper limit of normal reference value; serum creatinine > upper limit of normal reference value; blood leukocyte <3.0×109/L or >10.0×109/L; and/or neutrophil (N) classification >80%; body temperature =37.3?;
- •(3) Patients taking angiotensin-converting enzyme inhibitors (ACEI);
- •(4) within 24 hours of taking drugs that cause adverse reactions to cough, or receiving drugs and non-drug treatments with antitussive, phlegm-relieving, and spasmolytic effects;
- •(5) Combined with serious primary diseases of cardiovascular and cerebrovascular, liver, kidney, respiratory system, circulatory system, autoimmune system and hematopoietic system, or serious diseases that affect their survival, such as tumor or AIDS; of disabled patients; abnormal chest X-ray, not excluding inflammation or space-occupying lesions;
- •(6) A history of alcohol and drug abuse or drug use in the past year;
- •(7) Pregnant or lactating women or those who are unwilling to take contraceptive measures during the test and within 1 month after the end of the test;
- •(8) Participated in another drug study within three months prior to enrollment;
- •(9) Those with allergic constitution or known ingredients of the drug;
- •(10) The investigator determines that there are other factors that are not suitable for inclusion.
研究者
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