Study On The Efficacy And Safety Of Jinqiaoreduqing Granules In The Treatment Of Common Cold With Wind-heat Syndrome

BackgroundJinqiaoReduqing granules was a self-development preparation of Zhujiang Hospital.It has the effect of expelling wind and clearing heat,detoxifying,relieving sore throat and cough,and was mainly used to treat common cold with wind-heat syndrome(CCWHS)in the clinical.As a traditional Chinese medicine preparation,although the efficiency and safety of JinqiaoReduqing granules in the treatment of CCWHS has been confirmed in the clinical,there was no standardized clinical trial has been conducted to confirm its efficacy and safety.Therefore,a standardized clinical trial is needed to asses the efficacy and safety of JinqiaoReduqing granules in the treatment of CCWHS and to provide basis for its further clinical use.ObjectiveTo assess the efficacy and safety of JinqiaoReduqing granules in the treatment of CCWHS and to provides the basis of the clinical use of JinqiaoReduqing granules.MethodsA randomized,double-blind,double-dummy,parallel,positive-controlled trial was performed.Participants were collected prospectively from the department of traditional Chinese medicine in Zhujiang Hospital,and were randomly assigned to experimental group(JinqiaoReduqing granules group,JQRDQ group)and control group(Lianhuaqingwen capsules group,LHQW group).Patients in JQRDQ group received a bag of JinqiaoReduqing granules and four dummy Lianhuaqingwen capsules per time,three times daily for 4 days.Patients in LHQW group received four Lianhuaqingwen capsules and a bag of dummy JinqiaoReduqing granules per time,three times daily for 4 days.All patients’ temperature were measured and recorded in their first visit to hospitalization.For those patients whose body temperature was ≥37.3℃ body temperature were measured every hour after taking the drug for the first time,4 times in a row.And in the following three days,temperature were measured at 10:00、14:00、20:00 everyday.For those patients whose body temperature was normal(<37.3 ℃),temperature were measured at 14:00 everyday for 4 days.Patients went back to the hospital in the forth day after their first dose.Their traditional Chinese medicine(TCM)symptom score and laboratory examination indexes were recorded in the first and second visits to the hospital.Temperate changes,TCM symptom scores before and after treatment,time to fever relief,time to fever clearance were compared between two groups.Total markedly effective rate and total effective rate were also calculated and compared between two groups.Results1.76 patients were enrolled in this study.After eliminating candidates who did not fit the requirements,a total of 72 patients were eligible for our clinical trial.Among them,36 patients were assigned to the treatment group(JQRDQ group)and 36 patients were assigned to the control group(LHQW group).There were no statistically differences in demographic variables such as age,gender,temperature,TCM symptom score between the two groups,so these demographic variables are comparable.2.The comparison of efficacy between groups.The total effective rate was 97.2%in treatment group and was 100%in control group,but the difference of total effective rate between the two groups was not statistically significant(P=1.00).The difference of total markedly effective rate between groups was also not statistically significant(P=0.78).The result of non inferiority test showed that the total effective rate and total markedly effective rate in treatment group were not inferior to that in control group.3.The comparison of time to fever relief and time to fever clearance between groups.The median time to fever relief was(4.00±7.78)h in JQRDQ group and was(4.00 ± 5.46)h in LHQW group.There was no significant difference between two groups in the median time to fever relief(P=0.27).No significant difference was found in the median time to fever clearance between the two groups(P=0.679).4.The comparison of TCM symptom score between groups.Before treatment,the mean TCM symptom score in JQRDQ group was 16.25 ± 4.49,after treatment,the score was 3.03 ± 2.95.TCM symptom score was significantly reduced after treatment in JQRDQ group(P=0.00).In LHQW group,the mean TCM symptom score before treatment was 18.39 ± 5.53,TCM symptom score after treatment was 3.19±2.95.TCM symptom score was significantly reduced after treatment in LHQW group(P=0.00).However,the difference of the mean TCM symptom score after treatment between two groups was not statistically significant(P>0.05).5.The study of safety.The value of liver and kidney function,routine urine and other tests had no obvious change before and after treatment in two groups.Besides,no serious adverse events was reported during the study.ConclusionBoth the total effective rate and total markedly effective rate of JinqiaoReduqing granules in the treatment of CCWHS is not inferior to Lianhuaqingwen capsules and no adverse events was reported during the study.Therefore,JinqiaoReduqing granules was thought to be effective and safe in the treatment of CCWHS,however,more clinical research with larger sample size is needed to confirm this conclusion.