NCT03830684

A Randomized, Double-blind, Placebo-controlled, Multicenter and Phase Ⅱa Clinical Trial for the Effectiveness and Safety of Baicalein Tablets in the Treatment of Improve Other Aspects of Healthy Adult With Influenza Fever

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with influenza

Detailed description

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.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Baicalein Tablets 400mg	4 Baicalein Tablets and 2 placebo per time, three times a day
DRUG	Baicalein Tablets 600mg	6 Baicalein Tablets per time, three times a day
DRUG	blank control 0mg	6 placebo per time, three times a day

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-05-31
• Completion: 2019-10-31
• First posted: 2019-02-05
• Last updated: 2019-02-05