Sense Of Clear Solution Resistance Granules In Treatment Of Acute Upper Respiratory Tract Infection Table Cold Heat Ⅱ Period In Clinical Research

Objects:With the placebo control, initially, to evaluate the curative effects of the Qingjiekanggan Grain treating acute upper respiratory tract infection(Superficies cold and interior heat syndrome),proper dose and the security of Qingjiekanggan Grain.Methods:This test uses a placebo-controlled, randomized, double-blind, multi-center trial design method. Throughout the trial by GuangAnMen Hospital, China Academy of Traditional Chinese Medicine, First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Longhua Hospital Affiliated to Shanghai University of TCM, Shuguang Hospital, Shanghai Chinese Medicine Hospital of five research centers together to complete48cases per center.1.The clinical data:Test to select patients from March2010to September2010, the five research centers, emergency/outpatient received240cases of acute upper respiratory tract infection (Superficies cold and interior heat syndrome) Stratified random randomized to receivethree groups of subjects8g dose group,4g dose group and the placebo group of the80cases, namely A, B, C group; The three groups at baseline between the two groups, the difference was not statistically significant (P>0.05).2.Drug usage:GroupA:Qingjiekanggan Grain, boiled water,2bags,3times/day;B Group:Qingjiekanggan Grain, boiled water,1bag,3times/day placebos,1bag,3times/day; C:placebos, boiled water,2bags,3times/day. During the test shall not be related to the treatment of the disease and Western anti-virus, hormones, antipyretic analgesic drugs and treatment methods. Combined with other diseases must continue taking other drugs and treatment methods, detailed records must be in the combination therapy table.3.The effectiveness of evaluation:Evaluation of the effectiveness of the drug disease efficacy, syndromes, respiratory symptoms on the survey scale-21version (WURSS-21) score change in body temperature, TCM individual symptoms and Wisconsin.4.Adverse events observed:Vital signs before and after the test, three conventional random venous blood glucose, ECG, liver function (ALT, AST, TB1L, TP, ALB) and renal function (BUN, Cr), and to keep detailed records appearadverse events.5.Statistical methods:Statistical analysis was performed using SAS6.12 statistical analysis software, statistical analysis plan is ultimately determined by the principal investigator, statistician, the sponsor. All statistical tests were two-sided test, P values less than or equal to0.05was considered to test a statistically significant difference.Results:Heating effect, no significant difference between the three groups. A group in traditional Chinese medicine syndromes markedly effective rate, the efficacy of individual symptoms, Wisconsin efficacy of respiratory symptoms were better than the other two groups. There were five adverse events, which the Group B, C, the incidence of adverse events were2.5%and3.8%, respectively. The incidence of adverse events between the two groups, the difference was not statistically significant. In five cases of adverse events, serious adverse events occurred in the C group.Conclusions:Initial display Qingjiekanggan Grain in the treatment of acute upper respiratory tract infection (Superficies cold and interior heat syndrome) safe and effective the recommended Phase Ⅲ clinical trials usage of8g,3times/day. Approved by the State Food and Drug Administration (approval document No.2008L11134) Phase Ⅲ clinical trials in eight research units.