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A Randomized, Controlled Clinical Study on the Efficacy and Safety of Xiao'er Diquqingre Syrup for the Treatment of Acute Upper Respiratory Tract Infections in Children

A Randomized, Controlled Clinical Study on the Efficacy and Safety of Xiao'er Diquqingre Syrup for the Treatment of Acute Upper Respiratory Tract Infections in Children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001181
Enrollment
Unknown
Registered
2026-05-07
Start date
2026-03-09
Completion date
Unknown
Last updated
2026-06-01

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

Experimental Group:Pediatric Chiqiao Qingre Syrup, oral administration, 3 times daily, course of 3 days
1-3 years old: 15ml per dose, 4-6 years old: 20ml per dose, 7-9 years old: 25ml per dose, 10-13 years old: 30ml per dose.
Control Group:Pediatric Diquqing Heat Granules: dissolve in boiling water, take three times daily, for a 3-day course
dosage: 3 grams per dose for children aged 1-3 years, 4 grams per dose for 4-6 years, 5 grams per dose for 7-9 years, and 6 grams per dose for 10-13 years.

Sponsors

Central Hospital of Hunan University of Medicine and Health (formerly Huaihua City First People's Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. Age 1-13 years old, gender; 2. Meets the diagnostic criteria for acute upper respiratory tract infection in Western medicine; 3. Body temperature within 24 hours prior to consultation is 37.2? to 39? (including 37.2? and 39?), and fever duration =48 hours; 4. The legal guardian of the child signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Children with concurrent respiratory system diseases or pulmonary diseases; 2. Children with herpangina, pharyngoconjunctival fever, suppurative tonsillitis, lower respiratory tract infections, or respiratory infectious diseases; 3. Children with a history of epilepsy or febrile seizures, or recurrent respiratory infections; 4. Children with severe malnutrition, rickets, or concurrent severe systemic diseases such as cardiovascular, cerebral, hepatic, renal, or hematopoietic system disorders, or mental illness; 5. Children with known allergies to the components of the investigational drug; 6. Children who have participated in other clinical trials within the past three months.

Design outcomes

Primary

MeasureTime frame
Body Temperature;

Secondary

MeasureTime frame
Complete defervescence time;Immediate fever reduction time;Traditional Chinese Medicine (TCM) Syndrome Efficacy;

Countries

China

Contacts

Public ContactLuo Qilin

Central Hospital of Hunan University of Medicine and Health (formerly Huaihua City First People's Hospital)

Luoqilin898@163.com13974538918

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026