ITMCTR2000003489尚未招募4 期
Efficacy and safety of Jinzhen oral liquid (cough due to phlegmheat) in the treatment of acute bronchitis in children: a randomized, double-bind, parallel controlled, multicentric clinical trial
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
- 性别
- All
入选标准
- •1. Children who meet the diagnosis criteria of acute bronchitis in children;
- •2. Children who meet the diagnostic criteria of TCM syndrome of phlegm-heat obstructing lung;
- •3. Age: 2-14 years (>= 2 years, < 15 years);
- •4. Cough (daytime + nighttime) score >= 4 points;
- •5. The course of disease is <= 48 hours, and antibiotics, antitussive and expectorant medicines and other TCM and Western medicines that have therapeutic effects on cough were not used before enrollment;
- •6. The informed consent process was in accordance with the regulations, and the legal representative or the child ( >= 8 years old) signed the informed consent jointly.
排除标准
- •1. Children with severe bronchitis or early pneumonia;
- •2. Children with acute infectious diseases such as measles, pertussis and influenza
- •3. Children with diseases such as acute upper respiratory tract infection, suppurative tonsillitis, wheezing bronchitis, bronchial asthma, bronchiolitis pneumonia, tuberculosis, tumor
- •4. White blood cell count > 12.0 x 10^9/L, or large amount of purulent sputum;
- •5. Children with severe malnutrition and immunodeficiency;
- •6 Children with severe primary diseases such as heart, liver, kidney, digestion and hematopoietic system;
- •7. Children who are allergic to components of Jinzhen oral solution and ambromoterol oral solution;
- •8. Children who are taking epinephrine, isoproterenol and other catecholamines;
- •9. Children who are taking MAO inhibitors or tricyclic antidepressants
- •10. Children who are taking non-selective ß-blockers such as Propranolol;
- •11. Children who are taking a lot of other sympathetic stimulants
- •12. Those who are not included based on the investigators judgment.
研究者
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