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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003489
Enrollment
Unknown
Registered
2020-07-15
Start date
2020-08-17
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute bronchitis in children

Interventions

Sponsors

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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, = 4 points; 5. The course of disease is = 8 years old) signed the informed consent jointly.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The disappearance time of cough;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactWu Shengxian

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

wushx@sina.com+86 13501382919

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026