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A multicenter, randomized controlled clinical study on the efficacy and safety of right-handed ibuprofen oral suspension in treating acute respiratory infections with fever.

A multicenter, randomized controlled clinical study on the efficacy and safety of right-handed ibuprofen oral suspension in treating acute respiratory infections with fever.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116566
Enrollment
Unknown
Registered
2026-01-12
Start date
2026-01-20
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

The fever caused by respiratory infections

Interventions

Experimental group:Right-handed ibuprofen oral suspension
Control group:Ibuprofen oral suspension (Melin)

Sponsors

Affiliated hangzhou first people's hospital, zhejiang university school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. The guardian consents to participate in the study, signs an informed consent form, and is able to cooperate with follow-up visits. 2. Children aged 1 to 12 years, with no gender restrictions. 3. Acute respiratory infections with fever. 4. Symptoms of fever, with an axillary temperature of 38.5°C or less but above 38.5°C. 5. The onset of clinical symptoms for this current episode is within the last 72 hours.

Exclusion criteria

Exclusion criteria: 1. Antipyretic drugs (including compound preparations containing antipyretic ingredients and Traditional Chinese Medicine Patent Prescriptions) used in the past 6 hours; 2. The use of glucocorticoids in the past 24 hours; 3. Severe abnormal liver and kidney function (ALT or AST > 2 times normal value); Creatinine (Cr) > 1.5 times normal line; 4. Persons who have signs of dehydration or a high fever threat at the time of their visit and who have had a high-temperature threat within the past 6 months; 5. Severe malnutrition; 6. Accompanied heart failure or other organ failure; 7. Children with a diagnosed tumor; 8. ulcers in the digestive tract or active bleeding; 9. Children with symptoms such as tuberculosis, sepsis, rheumatic fever, typhoid, localized pustular lesions and prolonged fever; 10. Allergic to this type of medication; asthma, rhinitis, or urticaria triggered by the use of aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs); 11.Chronic disorders of liver, kidney, endocrinology (such as uncontrolled diabetes mellitus), blood, heart, respiratory system, genetic and metabolic disorders and other critical illnesses; 12. Central nervous system disorders; 13. Rheumatic immune diseases (such as SLE, mixed connective tissue disease, etc.) 14. Have participated in clinical trials of other drugs within one month prior to the screening; 15. Other circumstances are considered unfit for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Temperature change 4 hours after administration;

Secondary

MeasureTime frame
The proportion of people with normal body temperature (<= 37.2?);Life signs, gastrointestinal symptoms, allergic reactions, other adverse events;Other adverse events;Temperature change 6 hours after administration;Change in fever comfort score;The average time for normalizing body temperature (= 37.2?);

Countries

China

Contacts

Public ContactChunming Jiang

Affiliated hangzhou first people's hospital, zhejiang university school of medicine

cm_jiang@126.com+86 571 56007568

Outcome results

None listed

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