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A multicenter randomized controlled clinical study of Yinlai Decoction in the treatment of children with influenza (pulmonary and gastric heat accumulation syndrome)

A multicenter randomized controlled clinical study of Yinlai Decoction in the treatment of children with influenza (pulmonary and gastric heat accumulation syndrome)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005417
Enrollment
Unknown
Registered
2021-12-17
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

influenza

Interventions

Sponsors

Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: ?1 year old < age = 12 years old; ? Meet the diagnostic criteria and syndrome differentiation criteria of influenza; ? Duration of fever =48 hours; ? The informed consent process is in accordance with the provisions, and the legal representative or the subject child (=8 years old) signs the informed consent together; ? Novel coronavirus nucleic acid test was negative.

Exclusion criteria

Exclusion criteria: ? Diseases with conjunctival pharyngeal fever, herpetic angina, suppurative tonsillitis and novel coronavirus infection that need to be identified with influenza; ? Influenza complications such as sinusitis, otitis media, bronchitis, etc.; ? Severe or critical cases of influenza; ? Antiviral drugs have been used within 48 hours before this visit; ? Positive systemic steroid therapy or other immunosuppressive therapy; ? Have a history of epilepsy or high fever convulsion, recurrent respiratory tract infection; ? Severe malnutrition, rickets children and complicated with heart, brain, liver, kidney and hematopoietic system serious primary diseases; ? to test drug allergy or allergic constitution (to two or more food or drug allergy); ? Other lesions or conditions that reduce the possibility of enrollment or complicate enrollment, such as unstable living environment, inconvenient transportation and other conditions that may easily lead to loss of follow-up, according to the judgment of the investigator.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Public ContactGU Xiao-hong
guxh1003@126.com13269333590

Outcome results

None listed

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