[Translation] Efficacy and safety of forsythiaside capsules (KD-1 capsules) in the treatment of acute influenza fever symptoms, randomized, double-blind, placebo-controlled, dose-finding, multicenter phase II clinical trial
主要目的:
观测流感发热患者的体温复常时间,评价连翘苷胶囊相较于安慰剂治疗流感相关发热症状消退时间方面的有效性。
次要目的:
(1)通过观测流感发热患者体温复常后的发热复发率、即刻退热时间、流感临床痊愈时间、流感症状缓解时间、流感症状改善程度、流感病毒转阴率、血清细胞因子-白细胞介素6(IL-6)水平,进一步评估连翘苷胶囊与安慰剂相比的有效性;
(2)通过观测流感发热患者的不良事件等安全性评价指标,评估连翘苷胶囊的安全性和耐受性;
(3)探索连翘苷胶囊治疗流感引起发热的最适剂量。
[Translation] main purpose:
To observe the normalization time of body temperature in patients with influenza fever, and to evaluate the efficacy of Forsythiaside capsules compared with placebo in the treatment of influenza-related fever symptoms subsidence time.
Secondary purpose:
(1) By observing the fever recurrence rate, immediate fever reduction time, influenza clinical recovery time, influenza symptom remission time, influenza symptom improvement degree, influenza virus negative conversion rate, serum cytokine-interleukin 6 (IL-6) levels to further evaluate the effectiveness of forsythiaside capsules compared with placebo;
(2) To evaluate the safety and tolerability of Forsythiaside Capsules by observing the safety evaluation indicators such as adverse events in patients with influenza fever;
(3) To explore the optimal dose of Forsythiaside Capsules for the treatment of fever caused by influenza.