NCT03186079

Efficacy of Chinese Herbal Medicine Xiaojidaozhi Decoction in the Treatment of Childhood Constipation

Efficacy of Chinese Herbal Medicine Xiaojidaozhi Decoction in the Treatment of Childhood Functional Constipation: a Double Blind, Randomized and Placebo-controlled Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Shengjing Hospital · Academic / Other
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

Constipation is the most common complaint in childhood gastrointestinal disease,affecting an estimated 20% of the global children.The treatment strategies consist of diet control,behavioural intervention and oral and sometimes rectal laxatives. Given higher success rate and fewer side effects,the laxative PEG3350 has been considered the first choice in childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting, additional treatment interventions are still necessary.With an unsatisfactory response to current treatments, many patients seek help from Chinese Herbal Medicine.In view of the traditional theory, childhood constipation is derived from weakness of gastric and splenic function.The functional weakness is characterized by food stagnation and further pathological heat accumulation in the gastrointestine. The food stagnation can slow the gastrointestinal motility while heat causes constipation by drying the intestines and their content. Therefore, the therapeutic principles and practices for childhood constipation must focus on the pathophysiological basis accordingly. In the documented traditional medicine dictionary(Pi Wei Lun), Xiaojidaozhi Decoction is well described in improving the gastric and splenic function, eliminating food stagnation and removing pathological heat accumulation, and it has always been used in treatment of constipation throughout Asia since the first description in Pi Wei Lun in 1249. It comprises twelve herbs. Through the combined action of these herbs, Xiaojidaozhi Decoction can increase fluid in the intestines and facilitate the gastrointestinal motility, relieving the symptoms of constipation. Despite of the long history of successful use of Xiaojidaozhi Decoction in childhood constipation, a large randomized placebo-controlled trial is still not available.The aim of this study was to explore the clinical efficacy and safety of Chinese herbal medicine Xiaojidaozhi Decoction in the treatment of childhood constipation.

Conditions

• Constipation
• Chinese Herbal Medicine

Interventions

Type	Name	Description
DRUG	Xiaojidaozhi Decoction	Mixture of twelve Chinese herbal medicines granule
DRUG	Placebo	Mixture of 10% Chinese herbal medicines granule and 90% artificial gum
DRUG	Fiberform	Fiberform is a low-phytate wheat fibre which can increase the gastrointestinal motility.
BEHAVIORAL	Toilet training	Toilet training has been considered a routine method in treatment of constipation

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2017-06-14
• Last updated: 2023-11-22

Locations

1 site across 1 country: China