cough variant asthma in children
Conditions
Interventions
Experimental group:Montelukast Sodium Chewable Tablets and Xiao'er Dingchuan Oral Liquid
Control group:Montelukast Sodium Chewable Tablets and placebo
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
3 Years to 13 Years
Inclusion criteria
Inclusion criteria: 1.It meets the diagnostic criteria of western medicine for cough variant asthma in children. 2.It meets the TCM diagnostic criteria of phlegm-heat stagnation of the lung syndrome. 3.The cough symptom score (daytime + nighttime) is >=4 points. 4.The age ranged from 3 to 13 years (= 8 years old) should jointly sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Children with chronic cough caused by gastroesophageal reflux cough, psychogenic cough, drug-induced cough, otogenic cough, congenital respiratory tract diseases, foreign body inhalation, respiratory tract infections caused by specific pathogens, protracted bronchitis, etc. as well as those with simple upper airway cough syndrome. 2.Those who have used asthma control therapies (such as inhaled glucocorticoids, leukotriene modifiers, long-acting ß2-receptor agonists, slow-release theophylline, systemic glucocorticoids, etc.) or relieving therapies (such as systemic rapid-acting ß2-receptor agonists, theophylline, etc.) before enrollment, as well as those who have used Traditional Chinese Medicines with cough-relieving phlegm-resolving and anti-asthma effects (including decoctions, decoction pieces, formulated granules and Chinese patent medicines), and are judged by the researchers to seriously affect the evaluation of baseline cough severity. 3.Children with severe malnutrition, rickets and severe primary diseases such as heart, brain, liver, kidney, hematopoietic system, spirit and nervous system. 4.Those who are allergic to the experimental drugs and their components. 5.Children who have participated in other clinical trials within one month. 6.Those considered by the researchers as not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cough symptom score (day+night); | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver Function;TCM syndrome scoring;Electrocardiogram;Complete Blood Count;Urinalysis;Renal function; | — |
Countries
China
Contacts
Public ContactLi Xinmin
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed