Clinical Population Pharmacokinetics/Pharmacodynamics Protocol of Alkaloids from Leaf of Alstonia scholaris on Acute Bronchitis Patients [post]

2019 unpublished
Acute tracheobronchitis is the acute tracheobronchial mucosal inflammation caused by biological, physical, chemical stimulation, and accompanied by symptoms of cough and expectoration. The capsule of alkaloids from leaf of Alstonia scholaris (CALAS), an effective part riches in alkaloids, has the antiviral, antibacterial, anti-inflammatory, expectorant, anti-tussive, anti-asthmatic, immunoregulation effects. However, whether the clinical indexes could be improved by the same ingredients and
more » ... ingredients and pathways after oral administration, and the changes in the relationship between ingredients and pharmacodynamics indexes, still need further clinical verification.Methods/design This is a prospectively planned, blinded, placebo-controlled, parallel-grouped clinical trial with aggregated population pharmacokinetics/pharmacodynamics (PPK/PD) data. 55 subjects will be randomly allocated into four arms, specifically, 10 of the 55 subjects were selected randomly for the placebo arm who will be orally administered with placebo (Tid), and 45 subjects were randomly assigned to CALAS treatment group (20 mg, 40 mg, 80 mg Tid, 15
doi:10.21203/rs.2.13848/v1 fatcat:htg44w5ttbeundazbbbip6mgjq