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A multicenter, randomized, double-blind, placebo-parallel controlled clinical trial on the efficacy and safety of acupoint application of traditional Chinese medicine in children with COVID-19 (mild) fever

A multicenter, randomized, double-blind, placebo-parallel controlled clinical trial on the efficacy and safety of acupoint application of traditional Chinese medicine in children with COVID-19 (mild) fever

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067218
Enrollment
Unknown
Registered
2022-12-29
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

children novel coronavirus pneumonia (COVID-19) (mild)

Interventions

Experimental group:Chinese medicine paste
Control group:Chinese medicine patch with placebo

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for novel coronavirus pneumonia (mild) or be diagnosed with novel coronavirus pneumonia (mild); 2. Aged range from 3 to 14 years (inclusive); 3. Body temperature >=37.3? (the body temperature in the consulting room on the day of treatment and the highest body temperature within 2 hours shall be considered); 4. No more than 48 hours have passed since the first onset of symptoms (or confirmed onset of illness); 5. Agreed to participate in the study, and the children's families/children signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Bacterial, fungal and other infections other than COVID-19 infection; 2. Patients with bronchial asthma, bacterial pneumonia, bronchitis, tuberculosis and other respiratory diseases; 3. History of febrile convulsions; 4. Patients with diabetes, tumor, liver, kidney, blood system and other serious diseases; 5. Patients with mental diseases; 6. Participate in other clinical studies within 30 days prior to the screening period; 7. Allergic constitution or allergy to known research drug ingredients.

Design outcomes

Primary

MeasureTime frame
Time for complete remission of fever;

Secondary

MeasureTime frame
Antipyretic onset time;Emergency antipyretic drugs (acetaminophen) usage;Individual symptom score 3 and 5 days after treatment;Adverse drug reaction;

Countries

China

Contacts

Public ContactJi Xiaohua

Xiyuan Hospital, China Academy of Chinese Medical Sciences

139111199408@163.com+86 139111199408

Outcome results

None listed

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