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A Randomized, Controlled, Multicenter Clinical Study on The Effectiveness of Xiaoer Qinggan granules in The Treatment of Influenza in Children

Evidence Based Evaluation of Traditional Chinese Medicine Prevention and Treatment Program for Children with Influenza

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003672
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-11-01
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 in Children

Interventions

Sponsors

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with influenza A (H1N1, H3N2) or influenza B virus according to real-time polymerase chain reaction (PCR) or virus culture; (2) Aged 5 to 14 years; (3) Armpit temperature >= 38 degrees C; (4) At least 2 systemic symptoms (headache, chills, myalgia or fatigue) and 1 respiratory symptom (cough, sore throat or rhinitis); (5) Those who meet the diagnostic criteria of TCM syndromes; (6) The course of the disease is within 72 hours; (7) Sign a written informed consent.

Exclusion criteria

Exclusion criteria: (1) Bronchitis, pneumonia, pleural effusion and interstitial lung disease confirmed by chest imaging (x-ray examination or CT); (2) Blood routine examination indicated bacterial infection; (3) purulent tonsillitis or purulent sputum; (4) Having primary diseases, such as blood diseases, bronchial asthma, liver diseases, kidney diseases, chronic congestive heart failure, and neurological diseases; (5) Antiviral drugs (amantadine, rimantadine, zanamivir or oseltamivir phosphate) were taken before the onset and inclusion of the study, or Chinese herbal medicines or proprietary Chinese medicines were taken. (6) Allergic to research drugs; (7) Take immunosuppressants within the last 3 months; (8) Participate in another clinical trial < 3 months prior to study randomization; (9) Acute respiratory infection, otitis or sinusitis 2 weeks before study inclusion; (10) Influenza vaccination within 6 months; (11) Other reasons suggested by the researchers. See Table 4 for inclusion and exclusion criteria.

Design outcomes

Primary

MeasureTime frame
The rate of cure;Defervescence time;Duration of disease;

Secondary

MeasureTime frame
The time between the start of treatment and the return to normal life (kindergarten or school);Disease severity;TCM syndrome score;Incidence of influenza complications;Frequency of use of antipyretic;Negative conversion rate of influenza virus;

Countries

China

Contacts

Public ContactWang Xue-Feng

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

lnzywxf@163.com+86 13840208807

Outcome results

None listed

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