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RCT study of Lianhua Qingwen Granule in treating RSV pneumonia

RCT study of Lianhua Qingwen Granule in treating RSV pneumonia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057146
Enrollment
Unknown
Registered
2022-03-01
Start date
2022-05-10
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

respiratory syncytial virus pneumonia

Interventions

Treatment group:Lianhua Qingwen Granule
Control group:Mimetic Lianhua Qingwen Granule

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Hospital of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. With reference to the practical pediatrics Zhufutang (8), in line with the western medicine diagnostic criteria for viral pneumonia; 2. Virological examination of RSV: positive (nasopharyngeal secretions of children were collected by colloidal gold method, and positive); 3. Meet the diagnostic criteria of pneumonia, cough and wind-heat pulmonary closure syndrome or phlegm-heat pulmonary closure syndrome in pediatrics of traditional Chinese medicine; 4. Within 5 days of onset; 5. Aged 1-14 years, no gender limit; 6. The legal guardian of the subject gives informed consent. Children aged >=8 years should also sign the children's informed consent form. The process of obtaining informed consent shall comply with GCP regulations.

Exclusion criteria

Exclusion criteria: 1. Suffering from diseases that need to be distinguished from respiratory syncytial virus pneumonia, such as tuberculosis, bacterial pneumonia and other pathogenic microbial pneumonia; 2. Use other antiviral drugs within 1 week before screening, including traditional Chinese medicine with antiviral indications; 3. Severe pneumonia; 4. Judging by the researchers, past or present suffering from illness, may affect the patients to participate in the test or influence the outcome of the study, including: hypertrophic cardiomyopathy, primary immunodeficiency disease, acquired immune deficiency syndrome, congenital respiratory tract malformation, pulmonary dysplasia, aspiration pneumonia, pulmonary malignant tumor diseases; 5. Patients with severe malnutrition, rickets, and severe primary diseases of heart, brain, liver, kidney and hematopoietic system; 6. Allergic constitution, such as allergic to two or more drugs or food, or known allergic to drugs related to this trial; 7. Patients deemed inappropriate for enrollment by other investigators.

Design outcomes

Primary

MeasureTime frame
temperature;cough;sputum;shortness of breath (number of breaths);lung auscultation;chest X-ray;

Secondary

MeasureTime frame
remission rate of secondary clinical symptoms;the time to remission of individual symptoms;hospital stay;duration of exacerbation (ICU transfer);incidence of pneumonia complications;combined utilization rate of antibiotics;

Countries

China

Contacts

Public ContactYuan Bin

Jiangsu Province Hospital of Chinese Medicine

yuanbin68358@163.com+86 13851463308

Outcome results

None listed

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