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The efficacy and safety of Shuanhuanglian oral solution(child type) in the treatment of acute upper respiratory tract infection (wind-heat-induced syndrome) in children: multicenter, randomized, double-blind, controlled trial

The efficacy and safety of Shuanhuanglian oral solution(child type) in the treatment of acute upper respiratory tract infection (wind-heat-induced syndrome) in children: multicenter, randomized, double-blind, controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003337
Enrollment
Unknown
Registered
2020-05-22
Start date
2009-11-06
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

Acute upper respiratory tract infection in children

Interventions

Sponsors

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. In line with the western medicine diagnostic criteria of acute upper respiratory tract infection; 2. In children caused by exogenous windd-heat cold disease diagnostic criteria; 3. Aged 1 to 7 years old; 4. The course of the disease is not more than 24 hours; 5. Parents or guardian signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Do not accord with standard of this disease diagnosis and syndrome dialectical criteria; 2. The early infantile acute infectious diseases, acute infectious laryngitis, suppurative tonsillitis, pneumonia, respiratory diseases such as bronchitis, capillary bronchitis; 3. The temperature38.5 degree C; 4. The pharyngeal swelling > 4 points; 5. WBC>12x10^9/L, CRP>10mg/L; 6. Has a history of febrile convulsion, severe malnutrition. Or with other heart, liver, kidney and hematopoietic system, such as serious primary diseases; 7. This research institute with medicine allergic constitution and composition are allergic; 8. Patients who are participating in clinical trials of other drugs; 9. According to the doctor, easy to cause loss of visitor.

Design outcomes

Primary

MeasureTime frame
temperature;

Secondary

MeasureTime frame
TCM syndrome changes;

Countries

China

Contacts

Public ContactZhonghua Guo

He'nan taloph pharmaceutical Limited by Share Ltd

gwnag@163.com+86 18637128964

Outcome results

None listed

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