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A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children

A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031599
Enrollment
Unknown
Registered
2020-04-05
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

acute pharyngitis and tonsillitis in children

Interventions

Sponsors

The First Teaching Hospital of Tianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of acute pharyngitis/acute tonsillitis; 2. Wind-heat syndrome or heat exuberance in lung and stomach syndrome in TCM; 3. Wong-Baker FACES Pain Rating Scale (WBS) of immediate sore throat >=4 , body temperature =8 years old) shall jointly sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. At the first diagnosis, the child's condition is more serious, and he/she suffers from poor mental state, irritability, headache, or limb muscle pain, and needs antipyretic and analgesic drugs; 2. Children or their parents/caregivers have difficulty understanding or cooperating with the use of WBS; 3. Children with peritonsillar or retropharyngeal abscesses, infectious mononucleosis, and measles and scarlet fever; 4. Children with severe primary diseases of heart, lung, liver, kidney, metabolism, hematopoietic, immune, nervous and spiritual systems; 5. Children with acute laryngitis, otitis media, bronchitis, pneumonia and other complications; 6. Allergic to the experimental drug (KHJS) and its components, and allergic to antipyretic analgesics; 7. Those who had taken acetaminophen, ibuprofen or other antipyretic analgesic within 6 hours before enrollment; 8. Those who the researchers deemed unsuitable for the study.

Design outcomes

Primary

MeasureTime frame
the time of producing analgesic effect;

Secondary

MeasureTime frame
duration of analgesic effect;AUC0-3h;rate of producing analgesic effect;rate of disappearance of sore throat ;effective rate of pharyngeal signs;changes of WBS(in days);efficiency of TCM syndrome;

Countries

China

Contacts

Public ContactZhongChengliang

First Teaching Hospital of Tianjin University of TCM

Clitripro@sina.com+86 13920392309

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026