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

Phase 2

Completed

• Conditions: Acute upper respiratory tract infection in children

• Registration Number: ITMCTR2000003337
• Lead Sponsor: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
temperature;

Secondary Outcome Measures

Name	Time	Method
TCM syndrome changes;