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Cohort study on the safety and efficacy of meiyoutong in treating fever in children

Cohort study on the safety and efficacy of meiyoutong in treating fever in children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102698
Enrollment
Unknown
Registered
2025-05-19
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Fever

Interventions

D-ibuprofen group (nonintervention study):None
Ibuprofen group (nonintervention study):None

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 3 Years

Inclusion criteria

Inclusion criteria: (1) The first-degree relatives/guardians of the child patient voluntarily participate in this study, sign the informed consent form, and are able to cooperate with clinical follow-ups. (2) The age of the child patient meets 1 year old = 38.5°C and < 41°C) caused by special diseases are excluded.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of asthma, heart failure, gastrointestinal ulcer and bleeding, and serious primary diseases such as cardiovascular, cerebrovascular, hematopoietic system and malignant tumors, or less than 6 months after the end of treatment. (2) Patients with high bleeding risk, including patients with congenital bleeding diseases (such as hemophilia), thrombocytopenia (platelet count less than 80×10^9/L), coagulopathy (PT/APTT/TT higher than 1.5 times the upper limit of normal), or patients with a history of diseases related to abnormal platelet function. (3) Patients who are known to be allergic to this product, or who have asthma, urticaria, or allergic reactions to ibuprofen or other non-steroidal anti-inflammatory drugs. (4) Patients with a history of gastrointestinal bleeding or perforation after the use of nsaids. (5) Patients with a history of active gastrointestinal ulcer/bleeding or spontaneous bleeding or an increased risk of cerebral hemorrhage. (6) Use of other antipyretic drugs in a short period of time (ibuprofen, acetaminophen for 4 hours, other non-steroidal anti-inflammatory drugs for more than 12 hours) was eligible. (7) Children with severe malnutrition. (8) Patients with signs of dehydration or high fever crisis. (9) Rare hereditary fructose intolerance, glucose/galactose malabsorption, or sucrase-isomaltase deficiency. (10) Children with tuberculosis, septicemia, rheumatic fever, typhoid fever, local suppurative lesions and other symptoms and prolonged fever. (11) Subjects who may not be able to complete the trial or comply with the requirements of the trial in the opinion of the investigators.

Design outcomes

Primary

MeasureTime frame
The change in body temperature 4 hours after administration;

Secondary

MeasureTime frame
The proportion of individuals with normal body temperature (=37.2°C) 4 hours after administration.;6 hours after medication Body temperature decline rate;12 hours after medication (12 hours after the first medication after admission) Number of medication administrations;The average time to normalize body temperature (=37.2°C);24-hour symptom evaluation;

Countries

China

Contacts

Public ContactChen Zhuanggui

The Third Affiliated Hospital of Sun Yat-sen University

chenzhuanggui@126.com+86 189 2210 3543

Outcome results

None listed

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