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Clinical Study on Qingre Dingjing Powder in the Treatment of Acute Respiratory Infections with High Fever in Children

Clinical Study on Qingre Dingjing Powder in the Treatment of Acute Respiratory Infections with High Fever in Children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002057
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Acute Respiratory Infection with High Fever

Interventions

Experimental Group:Qingre Dingjing Powder + Ibuprofen Suspension + Symptomatic Treatment
Control Group:Ibuprofen Suspension + Symptomatic Treatment

Sponsors

Jinan Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: (1) Age 1-6 years (inclusive), no gender restrictions; (2) Meet clinical diagnostic criteria for acute respiratory infection; (3) Meet diagnostic criteria for high fever (axillary temperature =39.0?); (4) Legal guardian consents to participate and signs informed consent.

Exclusion criteria

Exclusion criteria: (1) Respiratory infections caused by primary diseases: primary immunodeficiency, AIDS, congenital respiratory malformations, congenital heart disease. (2) Respiratory infections caused by other primary diseases: pneumonia, lung abscess, tuberculosis, bronchiectasis, asthma, bronchial foreign body, hyperthyroidism, rheumatic fever. (3) Children with diarrhea, acute gastroenteritis or other digestive system diseases. (4) Diabetes, rickets, calcium/phosphorus metabolism disorders, or severe malnutrition. (5) Severe primary diseases of heart, liver, kidney or hematopoietic system; abnormal liver/kidney function (ALT/AST =1.5×ULN, SCr >ULN). (6) Glucose-6-phosphate dehydrogenase deficiency (favism). (7) Severe allergies, suspected drug component allergy, or contraindications. (8) Participation in other drug trials within 1 month. (9) Other conditions deemed unsuitable by investigators.

Design outcomes

Primary

MeasureTime frame
Fever Onset Time, Defervescence Time, Complete Fever Resolution Time;

Secondary

MeasureTime frame
Body Temperature Monitoring;Blood Routine and C-Reactive Protein;Disappearance Time of Main Accompanying Symptoms;Wong-Baker FACES Pain Rating Scale;Clinical Efficacy;Incidence of Febrile Convulsions;Ibuprofen Usage;

Countries

China

Contacts

Public ContactXiang Ma

Jinan Children's Hospital

maxiang0176@163.com15965626966

Outcome results

None listed

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