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A multicenter randomized controlled clinical study of Kanglebao II formula in the treatment of children with influenza (lung and stomach heat accumulation syndrome)

A multicenter randomized controlled clinical study of Kanglebao II formula in the treatment of children with influenza (lung and stomach heat accumulation syndrome)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054426
Enrollment
Unknown
Registered
2021-12-17
Start date
2022-11-11
Completion date
Unknown
Last updated
2022-11-20

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

Conditions

influenza

Interventions

Experimental group:Kanglebao II formula

Sponsors

Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Aged 1 to 12 years; 2. Meet the influenza diagnostic criteria and dialectical criteria; 3. Fever duration =8 years old) signed the informed consent; 5. The new coronavirus nucleic acid test is negative.

Exclusion criteria

Exclusion criteria: 1. Combined with pharyngeal conjunctival fever, herpetic angina, suppurative tonsillitis, new coronavirus infection and other diseases that need to be differentiated from influenza; 2. Complications of influenza such as sinusitis, otitis media, bronchitis, etc. have occurred; 3. Severe or critical cases of influenza; 4. Antiviral drugs have been used within 48 hours before this visit; 5. Systemically receiving steroid therapy or other immunosuppressive therapy; 6. History of epilepsy or febrile convulsions, history of repeated respiratory tract infections; 7. Children with severe malnutrition, rickets and serious primary diseases of the heart, brain, liver, kidney and hematopoietic system; 8. Allergy or allergic constitution to the experimental drug (allergic to two or more foods or drugs); 9. According to the judgment of the researcher, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as unstable living environment, inconvenient transportation, etc., which may easily lead to loss to follow-up.

Design outcomes

Primary

MeasureTime frame
Time for complete fever reduction;Time of antipyretic effect;Fever reduction rate for 48h and 72h;

Secondary

MeasureTime frame
Chinese medicine symptom complex score;Clinical recovery time of disease;Negative rate of influenza pathogen detection in pharyngeal swabs;Incidence of complications, severe and critical diseases;Area under the curve of CARIFS symptom dimension score versus time;

Countries

China

Contacts

Public ContactGu Xiaohong

Beijing University of Chinese Medicine

guxh1003@126.com+86 13269333590

Outcome results

None listed

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