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A Randomized Controlled, Open-label, Multicenter Clinical Trial to Compare the Efficacy and Safety of Abidol Hydrochloride Tablets and Oseltamivir Phosphate Capsules in the Treatment of Influenza-Like Cases

A Randomized Controlled, Open-label, Multicenter Clinical Trial to Compare the Efficacy and Safety of Abidol Hydrochloride Tablets and Oseltamivir Phosphate Capsules in the Treatment of Influenza-Like Cases

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043928
Enrollment
Unknown
Registered
2021-03-05
Start date
2020-12-10
Completion date
Unknown
Last updated
2021-07-12

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

Conditions

Adult patients clinically diagnosed with flu-like illness

Interventions

Group A:Abidol Hydrochloride Tablets, 200 mg/time, tid, for 5 days
Group B:Oseltamivir Phosphate Capsules, 75 mg/time, bid, for 5 days

Sponsors

The Second Hospital Of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Signed informed consent; 2) Aged >= 18 years, male or female; 3) Body temperature >= 37.5 degree C, and flu-like symptoms: headache, nasal congestion, sore throat, cough, fatigue, muscle aches, chills/sweating, etc., except for upper respiratory tract infection, there is no other diagnostic basis.

Exclusion criteria

Exclusion criteria: 1) Allergic history and/or severe allergic constitution; 2) severe liver and kidney dysfunction; 3) high possibility of bacterial infection according to signs, symptoms or laboratory tests; 4) beginning to appear pulmonary exudative lesions; 5) researchers believe that the impact of the subject's safety of severe heart disease or a history of clinically significant arrhythmia (according to the ECG or history); 6) the use of influenza vaccine within 12 months; 7) known HIV infection; 8) pregnant or lactating women; 9) researchers believe that not suitable for the group.

Design outcomes

Primary

MeasureTime frame
Time for body temperature to drop to normal and return to normal life and work;

Secondary

MeasureTime frame
Time to resolution of flu-like symptoms;Proportion of subjects with influenza-like related complications;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactTian Yingping

The Second Hospital of Hebei Medical University

tianyingping-jzh@163.com+86 13333015631

Outcome results

None listed

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