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Efficacy and safety of Xiao'er Chiqiao Qingre Syrup in treating pedo-anemopyretic cold in children with stagnant syndrome: a randomized, double-blind, double-simulation, original dosage form parallel-controlled, multicenter study

Efficacy and safety of Xiao'er Chiqiao Qingre Syrup in treating pedo-anemopyretic cold in children with stagnant syndrome: a randomized, double-blind, double-simulation, original dosage form parallel-controlled, multicenter study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000358
Enrollment
Unknown
Registered
2024-09-03
Start date
2019-12-20
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Pedo-anemopyretic cold in children with stagnant syndrome

Interventions

Control group:Xiao'er Chiqiao Qingre Granules (Sucrose Free)
Experimental group:Xiao'er Chiqiao Qingre syrup

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of Xiaoer Chiqiao Qingre syrup; 2. Meet the diagnostic criteria for common cold and have at least 1 nasal symptom and 1 pharyngeal symptom sign each with a score of =2; 3. Select children aged 1 to 13 years (<14 years); 4. Temperature =37.5°C within 24 hours prior to the consultation and duration of febrile illness =36 hours; 5.The informed consent process should be in accordance with the regulations, the legal guardian or with the subject child (=8 years old) to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Children with herpes pharyngitis, pharyngeal conjunctival fever, suppurative tonsillitis, lower respiratory tract infections or respiratory tract infections; 2. Children with a history of epilepsy or febrile convulsions, or recurrent respiratory infections; 3. A white blood cell count, absolute neutrophil count, and CRP, all exceeding 1.2 ULN and considered by the investigator to be bacterial infections 4. Children with severe malnutrition, rickets, or other cardiovascular, cerebral, hepatic, renal, and hematopoietic diseases, or psychiatric illnesses 5. Those with a history of allergic rhinitis, which has an impact on the evaluation of nasal symptoms; 6. Children who are allergic to known components of the test drug; 7. Children who have participated in other clinical trials in the 3 months prior to the trial 8. Other pathologies or conditions that, in the judgment of the investigator, have the effect of reducing the likelihood of enrollment or complicating enrollment, such as unstable living environments, transportation difficulties, and other conditions that could lead to loss of visits.

Design outcomes

Primary

MeasureTime frame
Single symptom efficacy;Complication rate;Disease efficacy rate;Chinese medicine evidence of healing rate;

Secondary

MeasureTime frame
Incidence of clinical adverse events/reactions;

Countries

China

Contacts

Public ContactXinmin Li/Siyuan Hu

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

husiyuan1963@sina.com022-27432716 / 13752009293

Outcome results

None listed

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