Phase Ⅱ Clinical Study of Lianhua Qingwen Capsule for Influenza / 中药新药与临床药理

ABSTRACT

Objective To evaluate the therapeutic effect and safety of Lianhua Qingwen Capsules (LHQC) in the treatment of influenza. Methods A multi- center, randomized, double- blind, positive- controlled, parallel group trial was designed. A total of 240 cases, which were diagnosed with influenza and classified as the syndrome of toxic heat invading lung, aged from 18 to 50 years old, with body temperature over 38.0 ℃ and disease course with 48 hours, was recruited. The intent- to- treat infected (ITTI) population was 152 cases , among which 76 were treated with LHQC (4 capsules thrice daily for 3 days) and other 76 with Lingyang Ganmao Capsules (2 capsules thrice daily for 3 days). Results In the ITTI population, the effective rate for subsiding fever was 71.1 % and 53.9 % (P=0.029), and that for relieving TCM symptoms was 73.7 % and 55.3 % (P=0.018) in LHQC group and Lingyang Ganmao Capsules group, respectively. A safety analysis was conducted in 233 cases. No adverse action was found in LHQC group while two adverse events (allergic dermatitis and diarrhea) in Lingyang Ganmao Capsules group. Conclusion Early application of LHQC is effective and safe in treating infuenza.