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A randomized controlled clinical trial on the efficacy and safety of Qingxuan Zhike Granule combined with oseltamivir phosphate granules in the treatment of children with influenza (wind heat invading the lung syndrome)

A randomized controlled clinical trial on the efficacy and safety of Qingxuan Zhike Granule combined with oseltamivir phosphate granules in the treatment of children with influenza (wind heat invading the lung syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070500
Enrollment
Unknown
Registered
2023-04-13
Start date
2023-04-28
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Influenza in children (wind heat attacking lung syndrome)

Interventions

Experimental group:Qingxuan Zhike Granule, oral, 1-3 years old: 1/2 pack each time
4~6 years old: 3/4 packs
7~14 years old: 1 bag each time
Three times a day. Oseltamivir phosphate granules, oral, weight 15~23kg, 3 bags at a time
Weight>23~40kg, 4 bags at a time
Weight >40kg, 5 bags, 2 times a day. If the age is 13 years old or older, take 5 bags twice a day.
Control group:Oseltamivir phosphate granules, oral, weight 15~23kg, 3 bags at a time
Weight>40kg, 5 bags at a time, 2 times a day. If aged >= 13 years, take 5 bags at a time, 2 times a day. Course of treatment: Treatment for 5 days. The drug was stopped and observed for 2 days.

Sponsors

Yunnan Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. According to the clinical diagnostic criteria of influenza in children, the colloidal gold immunochromatography test was positive; 2. In line with the TCM children influenza wind heat invading lung syndrome standards; 3. Aged 1-14 years; 4. Duration of fever 8 years old) jointly signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Suffering from pharyngeal conjunctival fever, herpetic angina, suppurative tonsillitis, etc.; 2. Influenza complications have occurred, such as sinusitis, otitis media, pneumonia, nervous system injury, cardiac injury, myositis and rhabdomyolysis, septic shock, etc.; 3. Severe or critical cases of influenza; 4. Within 48 hours before this visit, anti-virus western medicine and heat-clearing and detoxicating Chinese patent medicine have been used; 5. White blood cell count is greater than 12 x 10^9/L and/or neutrophil percentage greater than 70%; 6. Influenza vaccine has been inoculated within 12 months before the test; 7. The positive system receives steroid treatment or other immunosuppressive treatment; 8. Have a history of epilepsy or febrile convulsion; 9. Patients with severe malnutrition, rickets and serious primary diseases of heart, brain, liver, kidney and hematopoietic system; 10. Allergic or allergic constitution to the test drug (allergic to two or more foods or drugs); 11. The researcher judged that there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as unstable living environment and inconvenient transportation, which may easily lead to loss of visit.

Design outcomes

Primary

MeasureTime frame
Canadian Acute Respiratory Disease and Influenza Scale (area under the curve of CARIFS symptom dimension score and time);Time of clinical recovery;Time for complete remission of fever;TCM syndrome;

Secondary

MeasureTime frame
Headache, body aches, pharynx, cough, nasal congestion, sneezing, runny nose and other TCM syndromes;The incidence of complications, severe diseases and critical diseases;

Countries

China

Contacts

Public ContactXiong Lei

Yunnan Provincial Hospital of Traditional Chinese Medicine

xlluck@sina.com+86 871 63620626

Outcome results

None listed

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