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[A multicenter randomized parallel-controlled study on the efficacy and safety of er xie ting granules in children
Insights
ER XIE TING GRANULES demonstrated significant efficacy in treating acute childhood diarrhea, including rotavirus enteritis. This herbal remedy proved safe and effective, with no significant drug-related adverse reactions observed in the study.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
- Traditional Chinese Medicine
Context:
- Acute diarrhea is a common childhood illness globally.
- Rotavirus is a leading cause of severe diarrhea in infants and young children.
- Evaluating novel therapeutic agents for pediatric gastroenteritis is crucial.
Purpose:
- To assess the efficacy and safety of ER XIE TING GRANULES for acute diarrhea in children.
- To compare ER XIE TING GRANULES with smectite powder in a randomized clinical trial.
- To investigate treatment outcomes in children with rotavirus enteritis.
Summary:
- A multicenter, randomized trial involving 1458 children showed ER XIE TING GRANULES significantly improved cure and total efficacy rates compared to smectite powder after 3 and 7 days.
- In children with rotavirus enteritis, ER XIE TING GRANULES also demonstrated superior efficacy rates.
- No significant drug-related adverse reactions were reported for ER XIE TING GRANULES.
Impact:
- ER XIE TING GRANULES represent a potentially effective treatment option for acute diarrhea in pediatric populations.
- The findings support the use of herbal medicine in managing common childhood infectious diseases.
- Further research could explore long-term outcomes and optimal dosing strategies.
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.
