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A Randomized Double-blind Parallel-controlled Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Xiao'er Fengreqing Oral Liquid in Treating Acute Pharyngitis/tonsillitis (Externally-induced Wind-heat Syndrome) in Children

A Randomized Double-blind Parallel-controlled Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Xiao'er Fengreqing Oral Liquid in Treating Acute Pharyngitis/tonsillitis (Externally-induced Wind-heat Syndrome) in Children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000569
Enrollment
Unknown
Registered
2024-10-18
Start date
2024-11-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Acute pharyngitis/tonsillitis in children

Interventions

Positive drug control group:Xiao'er Fengreqing Oral Liquid placebo +Xiaoer Yanbian Granules
treatment group:Xiao'er Fengreqing Oral Liquid+Xiaoer Yianbian Granules placebo

Sponsors

Beijing University of Chinese Medicine Third Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Meet Western medical diagnostic criteria for acute pharyngitis and/or acute tonsillitis in children; 2. In line with TCM children acute milk moth and/or acute throat arthralgia external wind-heat syndrome differentiation standards; 3. Duration =48 hours and WBS pharyngodynia score =4 points at baseline; 4. The highest axillary temperature at the time of treatment was < 38.5?; 5. Within 48 hours before treatment laboratory examination reported that the blood white blood cell count =ULN (upper limit of reference value range); Neutrophil percentage =ULN (upper limit of reference value range); C-reactive protein =ULN (upper limit of reference value range); 6. Aged 3 to 14 years old (including 3 and 14 years old); 7. The informed consent process should be in accordance with the regulations and the legal guardian or the subject child (=8 years old) should sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pharyngeal symptoms or inflammation caused by diseases such as measles scarlet fever infectious mononucleosis agranulocytosis diphtheria suppurative tonsillitis herpetic angina and pharyngeal conjunctival fever; 2. Children with complications (such as infectious laryngitis bacterial otitis media acute bronchitis pneumonia etc.); 3. Have serious respiratory heart kidney liver blood endocrine nervous system and immune defects and other basic diseases; 4. Glucose-6-phosphate dehydrogenase deficiency (broad bean disease); 5. Allergic to known ingredients of the test drug; 6. Patients with a history of febrile convulsion; 7. Patients with diarrhea within 48 hours before treatment.

Design outcomes

Primary

MeasureTime frame
Effective rate and disappearance rate of WBS pharyngodynia after 5 days of administration;

Secondary

MeasureTime frame
Onset time and disappearance time of WBS sore throat;Effective rate and disappearance rate of pharyngeal pain after 3 and 5 days of medication;Effective rate and disappearance rate of total integral of TCM syndrome after 5 days of medication;Complete regression time;The onset time and disappearance time of pharyngeal pain in TCM syndrome;Integral effective rate and disappearance rate of individual symptoms/signs of TCM syndromes after 5 days of medication;Effective rate and disappearance rate of WBS pharyngodynia after 3 days of administration;

Countries

China

Contacts

Public ContactLiu Huilan

Beijing University of Chinese Medicine Third Affiliated Hospital

liuhlbj@163.com010-52075325

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 23, 2026