| Objective:The research aims to observe of the changes of Jiawei Gegen Decoction on cold (wind cold superficies syndrome) of TCM syndromes, TCM syndrome integral, body temperature, neutrophil recovery rate and lymphocyte recovery rate in order to evaluate the clinical curative effect of Jiawei Gegen Decoction in the treatment of common cold.Methods:1. Clinical data According to the diagnostic standard,120patients with cold were selected, and then divided into2groups through the design principle of randomized double blind parallel which were the test group and the control group with60cases in each group. Two groups of patients had comparable baseline datas.2. Drug usage Test group:Jiawei Gegen decoction, orally,100ml/bag,3times a day; Control group:Chill cold particles, orally,100ml/bag,3times a day. Observe the changes of symptoms, signs of two groups before and after treatment for3days.3. Monitoring project Therapeutic monitoring:TCM syndrome total score, Symptom integral, Body temperature, Neutrophil recovery rate, lymphocyte recovery rate; Safety monitoring:Vital signs, Electrocardiogram, liver and kidney function, Urine and Stool routine, Adverse events.4. Statistical analysis methods Statistic analysis would use the SPSS17.0statistical analysis software for calculation. All statistical tests were two-sided, and when the P value was less than or equal to0.05would be considered to have the statistical significance.Results:1. Symptomatic efficacy of TCM The cure rates and recovery rates of two groups showed significant differences after treatments(P<0.05).2. TCM Syndrome The comparison between two groups had significant differences in symptom total score changes before and after treatment (P<0.05), and the test group was better than control group.3. Symptom integral The therapeutic effects in aversion to cold, headache, limb pain, stuffy nose, runny nose and other symptoms had significant differences between two groups(P<0.05), and the test group was better than the control group. When the effects in throat itching, cough, phlegm thin or white, and thirst for hot drink after treatment level changes had no significant differences between groups (P>0.05).4. Temperature changes The two groups had no statistical significant differences between the groups at the first time in onset temperature (P>0.05). The differences between the two groups in recovery time of body temperature had statistical significant (P<0.05).5. Neutrophil, lymphocyte recovery rate The neutrophil recovery rates of two groups had no statistically significant after treatments (P>0.05). The lymphocyte recovery rate between the two groups had statistically significant differences after treatments (P<0.05), and the test group is better than the control group.6. Adverse events The two groups had no serious adverse reactions. The adverse reaction rates between the two groups had no significant difference(P>0.05).Conclusion:Jiawei Gegen Decoction was effective in the treatment of colds compared with Chill cold particles in the overall effect. |