A Phase 2 interventional study of Baicalein Tablets 400mg and Baicalein Tablets 600mg in Influenza, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-05.
Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Phase 2, Interventional, and Treatment
This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with influenza
This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with influenza, The trial designed by randomized, double-blind, placebo-controlled, multicenter and optimal efficiency. Subjects will be randomly assigned to low-dose group, high-dose group or placebo group as 1:1:1 proportionally, planned to enroll 180 subjects, each group enroll 60 subjects. The primary indicator is the time of fever relieving, comparison after the second visit. The secondary indicator are symptom alleviating time of influenza, percentage of subjects with influenza complications, percentage of antipyretic drugs used, percentage of virus positive to negative, comparison at the end of the experiment.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's planned enrollment of 180 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 161 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1.The patients with severe influenza or complication (e.g. secondary bacterial pneumonia, pneumonia caused by other pathogens or other viral pneumonia); 2.The patients with other acute upper respiratory tract infection (e.g. acute pharyngitis, tonsillitis, rhinitis and nasosinuitis); 3.Allergic to baicalin and its analogue, Paracetamol tablets, or allergic people; 4.Patients with any of the following risk factors:
Baicalein Tablets group
Drug: Baicalein Tablets 400mg
Baicalein Tablets group
Drug: Baicalein Tablets 600mg
control group
Drug: blank control 0mg
4 Baicalein Tablets and 2 placebo per time, three times a day
6 Baicalein Tablets per time, three times a day
6 placebo per time, three times a day
The time of fever relieving
After the first dose, the time of subjects' armpit temperature reduced to 37.3℃, and no longer increases in 24h.
Time frame: day 3
symptom alleviating time of influenza
The area under the curve (AUC) of the decline in the subjects' influenza symptom total score.
Time frame: day 3 and day 5
Percentage of subjects with influenza complications Percentage of subjects with influenza complications
Percentage of subjects with influenza complications, e.g. be hospitalized, death, sinusitis, otitis media, bronchitis, pneumonia, and so on.
Time frame: day 3 and day 5
Percentage of antipyretic drugs used
Percentage of the subjects used paracetamol.
Time frame: day 3 and day 5
Percentage of virus positive to negative
Percentage of subjects' influenza virus positive change to negative
Time frame: day 3 and day 5
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.