ITMCTR2000003489
Not yet recruiting
Phase 4
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
Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine0 sitesStarted: TBDLast updated:
Conditionsacute bronchitis in children
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Investigators
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