A multicenter randomized parallel-controlled study on the efficacy and safety of ER XIE TING GRANULES in children with acute diarrhea
10.3760/cma.j.issn.0578-1310.2013.09.007
- VernacularTitle:儿泻停颗粒治疗小儿急性腹泻病的多中心随机平行对照临床试验
- Author:
Clinical Research Collaborative Group of ER XIE TI
- Keywords:
Diarrhea,infantile;
Drugs,Chinese herbal;
Non-inferiority analysis
- From:
Chinese Journal of Pediatrics
2013;51(9):670-675
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of ER XIE TING GRANULES in children with acute diarrhea.Method A multicenter,randomized,open-label,parallel-controlled clinical trial was carried out in 15 hospitals during March 2011 to July 2012.A total of 1489 children with acute diarrhea were enrolled and divided randomly into two groups and treated with ER XIE TING GRANULES (treatment group)and smectite powder (control group).The therapeutic efficacy and adverse drug reactions were evaluated after three-day and seven-day therapy.Superiority or non-inferiority test was done for effectiveness of the treatment based on efficacy differ by more than 10％ regarded as the superiority.Result Totally 1458 children completed the study,in whom 726 children received ER XIE TING GRANULES and 732 received smectite powder.After three-day and seven-day therapy,cure rates and total efficacy rates of the treatment group were 44.2％,94.1％,88.8％,and 97.9％ separately and higher than those of control group (39.3％,88.4％,83.9％,97.4％) (Z =3.2,P ＜0.01 ;Z =2.46,P ＜0.05).There were 520 children with rotavirus infection and in whom 266 cases received ER XIE TING GRANULES and 254 received smectite powder.For rotavirus enteritis,cure rates and total efficacy rates of the treatment group after three-day and seven-day therapy were 40.6％,95.1％,89.9％,and 98.9％ separately and higher than those of control group (26.4％,84.3％,78.8％,and 96.8％) (Z=4.807,P＜0.01;Z=3.519,P＜0.01).The lower limits of the 95％ confidence interval of difference of cure rate and total efficacy rates after three-day and seven-day therapy between two groups were less than 10％.No obvious drug related adverse reactions were found during the study.Conclusion ER XIE TING GRANULES has the same effect for treatment of acute diarrhea and rotavirus enteritis in children.No obvious drug related adverse reactions were found.
