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A Multicenter Randomized Controlled Clinical Study on the Treatment of Mycoplasma Pneumonia in Children (Syndrome of Heat Pathogen Blocking the Lung) with Qingjin Tongluo Formula

A Multicenter Randomized Controlled Clinical Study on the Treatment of Mycoplasma Pneumonia in Children (Syndrome of Heat Pathogen Blocking the Lung) with Qingjin Tongluo Formula

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082333
Enrollment
Unknown
Registered
2024-03-26
Start date
2023-12-31
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Mycoplasma pneumoniae pneumonia in children

Interventions

Experimental group:Qingjin Tongluo Formula Combined with Azithromycin
Control group:Qingjin Tongluo Formula Simulator Combined with Azithromycin

Sponsors

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

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: Only those who meet all the following criteria can be selected: (1) Those who meet the Western medical diagnostic criteria for Mycoplasma pneumoniae pneumonia in children; (2) Those who meet the diagnostic criteria for traditional Chinese medicine syndrome differentiation; (3) Age range from 1 to 12 years old; (4) Within 48 hours of diagnosis of pneumonia; (5) Agree to cooperate with medication and undergo evaluation according to the requirements of the experimental protocol; (6) Must obtain the informed consent of the legal guardian of the subject and voluntarily sign the informed consent form; When the subject is able to make a decision to participate in a clinical trial, they must also obtain their own consent.

Exclusion criteria

Exclusion criteria: Those who meet any of the following criteria need to be excluded: (1) Clinically diagnosed with severe pneumonia; (2) Patients with concurrent episodes of respiratory diseases other than pneumonia; (3) Concomitant severe primary diseases such as heart, liver, kidney, digestive and hematopoietic systems; (4) Those who are clearly allergic to the experimental drug or its formulation components, or have allergic constitution; (5) Those who have participated in clinical trials within 3 months; (6) Researchers believe that individuals should not be included.

Design outcomes

Primary

MeasureTime frame
The total response rate of the disease;Time window for the efficacy of pediatric pneumonia;

Secondary

MeasureTime frame
TCM syndrome effect;Single symptom curative effect;Combined with medication use;Conversion rate;Serum inflammatory response related factors;Serum T cell subpopulations;

Countries

China

Contacts

Public ContactXuefeng Wang

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

lnzywxf@163.com+86 138 4020 8807

Outcome results

None listed

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