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Double-blind, double-simulation, multicenter, randomized controlled study of Qingfei Xiaoyan Pills in influenza treatment

Double-blind, double-simulation, multicenter, randomized controlled study of Qingfei Xiaoyan Pills in influenza treatment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002309
Enrollment
Unknown
Registered
2019-04-30
Start date
2019-06-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

influenza

Interventions

Control group:Oseltamivir phosphate capsule, 75mg*2 times/day*5 days
Experimental group:Qingfei Xiaoyan Pills, 60 pills * 3 times / day * 5 days

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1) Comply with influenza diagnosis; (2) The course of disease is = 36 hours; (3) Body temperature = 38 ° C; (4) At least one respiratory symptom (cough, sore throat, rhinitis), and at least one systemic symptom (headache, muscle pain, sweating or shivering, fatigue); (5) Positive detection of influenza virus nucleic acid antigen; (6) Aged 18 to 65 years; (7) The patient is informed and agrees to sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) pregnant women or women in puerperium. (2) Psychiatric patients, or others who cannot cooperate or are unwilling to cooperate. (3) Those who participated in other trials in the past 3 months. Receive flu vaccination within 12 months. (4) Receiving systemic steroids or other immunosuppressive agents. Participated in other trials in the past 3 months. (5) Significant chronic diseases (cardio-cerebral vascular disease, diabetes, malignant tumor, chronic obstructive pulmonary disease (chronic bronchitis, emphysema, etc.) or human immunodeficiency virus disease. Receiving systemic steroids or other immunosuppressants . (6) There was a history of alcohol or drug abuse. There are significant chronic diseases or human immunodeficiency virus diseases. (7) People who have taken antiviral drugs such as oseltamivir and amantadine to treat influenza. Has a history of alcohol or drug abuse. (8) Those who have taken antiviral drugs to treat influenza.

Design outcomes

Primary

MeasureTime frame
Median fever relief time;

Secondary

MeasureTime frame
Ibuprofen use total dose;Median cough relief time;Total flu symptom score;Median symptom relief time;

Countries

China

Contacts

Public ContactSu Rui

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

surui114@126.com+86 13260397833

Outcome results

None listed

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