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A multicenter, randomized, double-blind, placebo-controlled parallel clinical trial on the efficacy and safety of traditional Chinese medicine acupoint application in treating fever in children with upper respiratory tract infections

A multicenter, randomized, double-blind, placebo-controlled parallel clinical trial on the efficacy and safety of traditional Chinese medicine acupoint application in treating fever in children with upper respiratory tract infections

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000152
Enrollment
Unknown
Registered
2025-01-19
Start date
2023-12-06
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

upper respiratory tract infection

Interventions

comparison group:Chinese Medicine Patch Placebo
test group:application of Chinese medicine

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) Conform the diagnostic criteria for upper respiratory tract infection; (2) Age: 3 years old (including) -14 years old (including); (3) Temperature =37.3? (based on the temperature in the clinic on the day of consultation or the highest temperature within 2 hours, if antipyretic medication has been taken within 6 hours prior to the consultation, the temperature in the clinic or the temperature within 2 hours prior to the consultation, or the highest temperature in the temperature prior to taking antipyretic medication). ; (4) No more than 48 hours from the first appearance of fever (temperature =37.3°C); (5) Agreed to participate in the study and the child's family/child signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Comorbid respiratory diseases such as bronchial asthma, pneumonia, bronchitis, and tuberculosis; (2) Previous history of febrile convulsions; (3) Combination of diabetes mellitus, tumor and serious diseases of liver, kidney and blood system; (4) Combined psychiatric diseases; (5) Participation in other clinical studies within 30 days prior to the Screening Period; (6) Rash, eczema, skin lesions (e.g., scarring, ulcers) at the site of application; (7) Allergy or hypersensitivity to known components of the study drug.

Design outcomes

Primary

MeasureTime frame
Complete fever reduction time (body temperature);

Secondary

MeasureTime frame
Usage of emergency antipyretic drugs;Effective time for fever reduction (body temperature);Symptom rating;Fever recurrence time;

Countries

China

Contacts

Public ContactZhang Yunling

Xiyuan Hospital, China Academy of Chinese Medical Sciences

yunlingzhang2004@126.com010-62835001

Outcome results

None listed

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