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A randomized, double-blind, parallel controlled, multicenter clinical trial for the efficacy and safety of Bairui granule in the treatment of acute upper respiratory tract infection (wind heat syndrome) in children

A randomized, double-blind, parallel controlled, multicenter clinical trial for the efficacy and safety of Bairui granule in the treatment of acute upper respiratory tract infection (wind heat syndrome) in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003111
Enrollment
Unknown
Registered
2020-03-14
Start date
2020-04-03
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 (wind heat syndrome) in children

Interventions

Sponsors

Dongzhimen Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. It conforms to the diagnostic standard of Western medicine in children with acute upper respiratory tract infection; 2. Accord with syndrome differentiation standard of cold wind heat syndrome; 3. Aged >= 2 and = 37.3 degrees C and = 8 years old) sign the informed consent together.

Exclusion criteria

Exclusion criteria: 1. Children who have used other drugs to treat the disease (including cold medicine, antibiotics, antiviral drugs and similar traditional Chinese Medicine) within 24 hours before treatment; 2. Children with lower respiratory tract infection and infectious diseases such as bronchitis, bronchiolitis and pneumonia; 3. Total leukocyte count (WBC) >= 12 x10 ^9 / L or neutrophil absolute value (n) > 1.2 times the upper limit of reference value (ULN); 4. Children with history of epilepsy or febrile convulsion, children with recurrent respiratory tract infection; 5. Children with congenital immune deficiency, malnutrition, rickets, or other serious systemic diseases such as cardiovascular, brain, liver, kidney and hematopoietic system, among which ast, ALT > upper limit of reference value (ULN), bun > upper limit of reference value (ULN), SCR > upper limit of reference value (ULN); 6. Definitely diagnosed as children with mental development disorders; 7. Allergic constitution and children allergic to the test drug; 8. According to the judgment of researchers, it is easy to cause lost visitors.

Design outcomes

Primary

MeasureTime frame
Clinical recovery time;

Secondary

MeasureTime frame
Time of complete antipyretic;TCM syndrome integral;Disease recovery rate;Single symptom of traditional Chinese Medicine;

Countries

China

Contacts

Public ContactJunhong Wang

Dongzhimen Hospital Affiliated of Beijing University of Chinese Medicine

jhwang3158@126.com+86 13522958051

Outcome results

None listed

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