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Investigating the efficacy and mechanisms of Qingfei Tongluo Formula in the treatment of children with MP infection combined with CVA based on Th17/Treg immunological balance.

Investigating the efficacy and mechanisms of Qingfei Tongluo Formula in the treatment of children with MP infection combined with CVA based on Th17/Treg immunological balance.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001139
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-08
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Mycoplasma pneumoniae infection and cough-variant asthma

Interventions

Treatment group:Western medicine basic treatment + Chinese herbal medicine Lung-Clearing and Meridian-Connecting Formula
Control Group:Western medicine basic treatment +placebo

Sponsors

Tianjin Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 14 Years

Inclusion criteria

Inclusion criteria: The participants must meet the following criteria simultaneously: Meet the following conditions simultaneously: (1) Aged 5 - 14 years old, regardless of gender; (2) Meet the diagnostic criteria for Mycoplasma pneumoniae (MP) infection in children (symptoms of acute respiratory tract infection, and positive serum MP - IgM or positive MP - DNA PCR test of nasopharyngeal swab); (3) Meet the diagnostic criteria for cough variant asthma (CVA) in children (persistent cough > 4 weeks, often accompanied by nocturnal or early - morning attacks, positive bronchial provocation test or effective anti - asthma treatment); (4) Cough visual analogue scale (VAS) score = 30mm; (5) Meet the diagnostic criteria for wind - heat cough or phlegm - heat cough in traditional Chinese medicine (cough, yellow phlegm, discomfort in the throat, nasal congestion, yellow or turbid nasal discharge, red tongue with thin yellow or yellow greasy coating, floating and rapid or slippery and rapid pulse); (6) The legal guardians of the children voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Meet one of the following conditions: (1) Children with acute fever; (2) Patients with chronic cough due to other known causes (such as foreign body inhalation, whooping cough, pulmonary tuberculosis, etc.); (3) Patients with primary diseases of the heart, liver, kidneys, hematopoietic system, etc., or mental diseases; Known allergy to the study drug and its ingredients; (4) Systemic use of glucocorticoids or immunosuppressants within the past 4 weeks; (5) Other conditions that the researcher deems unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Daytime and Nighttime Cough Visual Analog Scale (VAS);Mycoplasma pneumoniae DNA(MP-DNA) conversion rate;

Secondary

MeasureTime frame
Pulmonary Function;Exhaled Nitric Oxide (FeNO);TCM Syndrome Score;Serum cytokines (IL-17A, IL-6, IL-10, TGF-ß);The proportion of Th17 and Treg cells in peripheral blood.;

Countries

China

Contacts

Public ContactZhao Jiuling

Tianjin Children's Hospital

jiuling999@163.com13752727039

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026