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Clinical research on the treatment of mycoplasma infectious bronchitis in children with Qingxuan Zhike Granules

Clinical research on the treatment of mycoplasma infectious bronchitis in children with Qingxuan Zhike Granules

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001306
Enrollment
Unknown
Registered
2025-06-30
Start date
2025-07-10
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Mycoplasma infectious bronchitis

Interventions

Control group:Ambroterol Oral Liquid, taken orally, twice a day, for a course of 7 days.
Experimental group:Qingxuan Zhike Granules, taken with warm boiled water, three times a day, for a course of 7 days.

Sponsors

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: Case inclusion criteria 1) Cough for 1 to 3 days; 2) Meets the following western medicine diagnosis and Chinese medicine identification criteria; 3) Age 1 to 14 years old (including both ends); 4) The informed consent process should be in accordance with the regulations and the legal guardian or with the subject child (=8 years old) should sign the informed consent form. Western medical diagnostic criteria: Diagnostic criteria were formulated with reference to Zhufutang Practical Paediatrics (8th edition) as follows: 1) Cough (=72h) fever with or without coughing up sputum red throat discomfort and other symptoms; 2) Rough breath sounds on lung auscultation or irregular scattered dry and wet rales; 3)X-ray lungs without changes or thickening of lung texture; 4)Positive MP-DNA test on pharyngeal swab or Mycoplasma pneumoniae IgM test =1:160. Chinese medicine identification criteria: The diagnostic criteria were formulated with reference to the Expert Consensus on Integrated Chinese and Western Medicine Diagnosis and Treatment of Acute Bronchitis in Children by the Paediatrics Specialty Committee of Jiangsu Society of Integrative Medicine and the Chinese Society of Integrative Medicine as follows: Wind-heat offending the lungs evidence: Primary symptoms: cough yellow or white sticky sputum or little sputum unpleasant sputum or dry cough; Secondary symptoms: 1) nasal congestion turbid runny nose or dry and hot nasal orifices; 2)Bad wind with sweating or fever; 3) Dry mouth and thirst; 4)Dry throat or even sore throat; Red tongue tip thin yellow or thin white dry tongue coating floating or floating pulse or floating purple fingerprints. The primary symptom is necessary the secondary symptom has 2 items and both the tongue and pulse can be identified.

Exclusion criteria

Exclusion criteria: Case exclusion criteria 1)MP pneumonia or multi-system and multi-organ damage; 2)There are various pathogenic bacteria infections in the respiratory tract and other lung diseases; 3) Children with severe liver kidney cardiovascular and hematopoietic system diseases immune system diseases and mental disorders; 4) Those who are allergic to known test drugs or components; 5) Patients who have participated in or are currently participating in clinical trials of other drugs within the past three months; 6) Children who based on the doctor's judgment cannot evaluate the therapeutic effect or are unable to complete the expected course of treatment and follow-up.

Design outcomes

Primary

MeasureTime frame
The effective rate of TCM syndromes;

Secondary

MeasureTime frame
Blood routine;Interleukin 18 (IL-18);Cough Visual Analogue Scale (VAS);X-ray chest film;Evaluation of the onset time of cough relief;Interleukin 4;Disease efficacy response rate;Cough Severity Score (CET);Interferon-gamma;Interleukin 17;

Countries

China

Contacts

Public ContactZhenqi Wu

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

zhenqiwu@163.com18102456617

Outcome results

None listed

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