The Clinical Study Of Randomized Double Blind And Parallel Control, Which Is To Compare The Efficacy Between "Qingqiao Kangdu Granules" Decocting-Free Granules And Traditional Decoction In The Treatment Of Common Cold With Exogenous Wind-Heat Syndrome

Background and purpose:"Qingqiao Kangdu granules" is a hospital preparation of Sichuan Province Hospital of traditional Chinese Medicine, which is effective, safe, low-cost and has been used in clinical for many years. This study researched the efficacy of two different dosage forms of "Qingqiao Kangdu granules" (decocting-free granules and traditional decoction)in the treatment of common cold with exogenous wind-heat syndrome.Methods:A randomized double blind and parallel control clinical trial was studied. A group of 60 patients of common cold with exogenous wind-heat syndrome was divided into experimental group and control group with 30 cases in each group. The control group took it using traditional decoction method to cook Chinese medicinal pieces; the experimental group took it also in liquid form using decocting-free granules with the same formula and same amount of traditional decoction. Patients of two groups were each administered 150ml medicine,3 times a day for 5 days. The differences were recorded and compared between the two groups before and after the treatment of TCM symptoms total score, TCM symptom score, TCM symptom curative effect, drug sensory index difference and recorded the cold symptoms disappear time during the treatment. A statistical analysis software SPSS 19.0 was used to compare the efficacy differences of two groups. Descriptive statistical analysis, qualitative indicators in percentage or proportion to describe; quantitative indicators using mean, standard deviation to describe. Qualitative data using chi square test, Fisher exact probability, Wilcoxon rank sum test in the comparison Analysis of two groups. Quantitative data accord with normal distribution using t test (homogeneity test of variance between the groups, with 0.05 as the standard test. Using the Satterthwaite method to correct the T test for variance nonhomogeneity), do not accord with normal distribution using the Wilcoxon rank sum test. Hypothesis testing all using two-sided test, given the statistics and the corresponding P values, with P lower than 0.05 was statistically significant.Results:60 patients were included in the full analysis set (FAS), the per-protocol set (PPS) and safety set (SS).1. The curative effect comparison of TCM individual symptoms (fever, chills, sore throat, sneezing, nasal congestion and runny nose, headache, hoarseness) between the groups was not statistically significant (P>0.05).2. The two groups of TCM symptoms total score were compared between groups had no statistical significance (P>0.05) before and after the treatment. TCM symptoms total score were compared between the two groups had no statistical significance (P>0.05) before and after the treatment.3. The comparison of TCM syndrome curative effect (in the cured and markedly effective, effective and ineffective) between the groups was not statistically significant (P>0.05).4. The comparison of symptoms disappear time in the treatment between the two groups was not statistically significant (P>0.05).5. The comparison of the sensory indicators (color, smell and taste) between the two groups was not statistically significant (P>0.05).6. Safety evaluation:The obvious toxic and side-effect, adverse events and adverse reactions were not found in the two groups.Conclusion:This topic through the randomized double blind, parallel control study showed that the intelligent free decoction and traditional decoction of "Qingqiao Kangdu granules" have the same efficacy in the treatment of common cold wind-heat syndrome type.