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The treatment of acute upper respiratory tract infection (wind heat syndrome) in children with Xiao'er Ganmaoning granules Multi center randomized double-blind parallel controlled clinical trial

The treatment of acute upper respiratory tract infection (wind heat syndrome) in children with Xiao'er Ganmaoning granules Multi center randomized double-blind parallel controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000782
Enrollment
Unknown
Registered
2024-12-09
Start date
2024-12-10
Completion date
Unknown
Last updated
2025-01-06

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

placebo group:Xiao'er Ganmaoning Granules Simulant, taken orally, diluted with boiling water, 4 times a day
Positive drug group:Children's Hot Speed Clear Granules+Children's Hot Speed Clear Granules Simulant (packaging 1 g of Children's Hot Speed Clear Granules and 1.5 g of Children's Hot Speed Clear Granu
Test drug group:Xiao'er Ganmaoning Granules, taken orally, diluted with boiling water, 4 times a day.

Sponsors

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 12 Years

Inclusion criteria

Inclusion criteria: (1) Meets the Western diagnostic criteria for acute upper respiratory tract infection in children; (2) Meets the diagnostic criteria for wind heat syndrome in traditional Chinese medicine; (3) The severity of the condition is moderate (defined as moderate or above symptoms of fever sore throat runny nose cough sneezing or nasal congestion); (4) Pre diagnosis course = 48 hours; (5) Age = 12 years old; (6) Prior to the study the consent of the legal guardian was obtained and a written informed consent form was signed (for patients aged = 8 years their supervision is required) Jointly signed by the guardians.

Exclusion criteria

Exclusion criteria: (1) Pharyngeal heat herpetic pharyngitis suppurative tonsillitis acute infectious laryngitis acute laryngitis Spasms acute epiglottis and other respiratory infections; (2) Respiratory infectious diseases such as influenza; (3) Patients with complications such as acute otitis media acute sinusitis acute bronchitis and pneumonia; (4) White blood cell count and neutrophil count exceed the upper limit of normal by 1.2 times and the researchers consider it as a bacterial infection; (5) Individuals with a history of epilepsy or febrile seizures; (6) Severe malnutrition rickets or other serious conditions affecting the cardiovascular brain liver kidney and hematopoietic systems Individuals with severe systemic diseases any respiratory anatomical abnormalities immune deficiencies or mental illnesses; (7) ALT and AST are 1.5 times higher than the upper limit of normal and blood creatinine (Cr) exceeds the upper limit of normal; (8) Individuals with glucose-6-phosphate dehydrogenase deficiency (fava bean disease); (9) Individuals who are allergic to known ingredients of the experimental drug; (10) Researchers believe that participants should not be included in the study; Select children who have participated in other clinical trials within the previous three months.

Design outcomes

Primary

MeasureTime frame
Disease recovery time;

Secondary

MeasureTime frame
Effective rate of traditional Chinese medicine syndrome;Incidence of complications;The disappearance rate of accompanying digestive symptoms (bloating decreased appetite bad breath dry stool);The use of antipyretic and analgesic drugs;Disappearance rate of individual symptoms;

Countries

China

Contacts

Public ContactYan Yongbin

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

yanyongbin8278@sina.com0371-66285929

Outcome results

None listed

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