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Clinical trial of central randomized, double-blind, dose exploration, multi-center, and two-stage adaptive design to evaluate the immediate pain relief effect and safety caused by pediatric acute pharyngitis (wind heat syndrome)

Clinical trial of central randomized, double-blind, dose exploration, multi-center, and two-stage adaptive design to evaluate the immediate pain relief effect and safety caused by pediatric acute pharyngitis (wind heat syndrome)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005988
Enrollment
Unknown
Registered
2022-05-10
Start date
2022-05-10
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Treatment of acute pharyngitis in children

Interventions

Very low dose group:1/20 crude solidago solidago spray, 15 ml/bottle.
Low-dose group:1/3 crude solidago solidago spray, 15 ml/bottle.
High dose group:Compound Solidago spray, 15 ml/bottle.

Sponsors

The Teaching Hospital of Tianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. Meet the western diagnostic criteria for acute pharyngitis. 2.It conforms to the standard of wind-heat syndrome differentiation. 3.Duration =2 days. 4.VAS score =4 at initial diagnosis of sore throat (dysphagia). 5.Children aged 6-13 years (< 14 years) can correctly use VAS scoring tools. 6.The informed consent process should comply with the regulations, and the legal guardian or the subject child (=8 years old) should sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Children or their parents/caregivers have difficulty in understanding or cooperating with the use of VAS. 2. At the time of initial diagnosis, the condition of the child is serious, such as lack of energy, restlessness, headache, or pain in body muscles, and antipyretic and analgesic drugs are needed. 3. Suppurative tonsillitis, abscess around tonsil or posterior pharyngeal wall, or white blood cell count, absolute value of neutrophil and CRP > ULN, which were considered to be caused by bacterial infection. 4.Children with measles, scarlet fever and other infectious diseases. 5.Children with acute laryngitis, otitis media, bronchitis, pneumonia and other complications. 6. Children with serious primary diseases of heart, lung, liver, kidney, metabolism, hematopoietic, immune, nervous, mental and other systems. 7. Allergic to the test drug (compound Solidago solidago spray) and its components, and allergic to antipyretic analgesics. 8.Patients who had taken acetaminophen, ibuprofen and other antipyretic and analgesic drugs within 6 hours before enrollment. 9.According to the judgment of the researcher, it is not suitable to be included in the group

Design outcomes

Primary

MeasureTime frame
pharyngeal pain;

Secondary

MeasureTime frame
Effective rate of pharyngeal signs;Disappearance time/disappearance rate of pharyngeal pain.;TCM syndrome effect.;Recovery rates.;VAS score for sore throat.;Time and duration of immediate analgesic effect.;

Countries

China

Contacts

Public ContactXinming Li

The Teaching Hospital of Tianjin University of TCM

bailing_stt@163.com15585776777

Outcome results

None listed

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