Modified Huoxiang Zhengqi Soft Capsule in treatment of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome: a multi-center and randomized controlled clinical trial / 药物评价研究

ABSTRACT

Objective To evaluate the efficacy and safety of Modified Huoxiang Zhengqi Soft Capsule in treatment of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome.Methods A multi-center and double-blind double-dummy randomized controlled trial was conducted.440 patients of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome were enrolled from Januarary to July 2013.They were randomly divided into two groups,the trial group of 330 cases and the control group of 110 cases.The trial group was given Modified Huoxiang Zhengqi Soft Capsule and Huoxiang Zhengqi Soft Capsule analogue three times a day for 3 days.The control group received Huoxiang Zhengqi Soft Capsule and Modified Huoxiang Zhengqi Soft Capsule analogue three times a day for 3 days.Clinical symptoms,signs and symptoms and adverse effect were observed and blood test,routine urine and stool test,feces occult blood,hepatorenal function and electrocardiogram were examined before and after treatment.Results In terms of traditional Chinese medicine syndrome and efficacy after treatment,the clinical healing rates of the trial group and the control group were 50.000％,35.455％ for full analysis set and50.464％,35.780％ for per protocol set.The overall effective rates were 94.848％,76.364％ for full analysis set and 96.285％,77.064％ for per protocol set.There were significant differences between the two groups (P ＜ 0.05).In addition,there were significant differences in clinical healing rates and overall effective rates of symptoms including diarrhea,nausea and vomiting,rhinobyon and rhinorrhea,fullness and oppression in the chest and diaphragm and abdominal swelling and pain between two groups (P ＜ 0.05).However,the difference in overall effective rates of headache and lightheadedness symptom were significant (P ＜ 0.05) except for clinical healing rate.No adverse effects were found in the trial.Conclusion Modified Huoxiang Zhengqi Soft Capsule is effective and safe in treatment of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome and its effect is better than that of Huoxiang Zhengqi Soft Capsule.