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

Phase 4

• Conditions: acute bronchitis in children

• Registration Number: ITMCTR2000003489
• Lead Sponsor: Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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;
11. Children who are taking a lot of other sympathetic stimulants
12. Those who are not included based on the investigators judgment.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The disappearance time of cough;

Secondary Outcome Measures

Name	Time	Method
Effect of TCM;AUC of the symptom scores for cough and expectoration;Onset time of cough;Disappearance rate of cough, sputum and lung rales;Cough symptom score;Time of clinical recovery;The use of antibiotics or antipyretics;