Skip to main content
OpenTrials
Completed

NCT Number: NCT03186079

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of childhood constipation
  • Criteria of constipation meets the Rome IV criteria(H3a)
  • Must be able to swallow capsules

Exclusion criteria

  • Digestive tract diseases
  • Neurologic diseases
  • Endocrine diseases
  • Metabolic diseases
  • Gastrointestinal surgery
  • Using drugs which can take impact on bowl motility

Treatment and study plan

Xiaojidaozhi Decoction

Drug

Mixture of twelve Chinese herbal medicines granule

Other names: XJD

Placebo

Drug

Mixture of 10% Chinese herbal medicines granule and 90% artificial gum

Other names: Placebos

Fiberform

Drug

Fiberform is a low-phytate wheat fibre which can increase the gastrointestinal motility.

Toilet training

Behavioral

Toilet training has been considered a routine method in treatment of constipation

Primary outcomes

  1. Percentage of overall efficacy

    Time frame: week 8(end of treatment)

    Efficacy is ranked as cured, improved, same/worse

  2. Percentage of overall efficacy

    Time frame: week 20(end of follow-up)

    Efficacy is ranked as cured, improved, same/worse

  3. Baseline of constipation score in the beginning of treatment

    Time frame: beginning of treatment(baseline)

    Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence

  4. Change of constipation score from the baseline in the end of treatment

    Time frame: week 8(end of treatment)

    Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence

  5. Change of constipation score from the baseline in the end of follow-up

    Time frame: week 20(end of follow-up)

    Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: Within week 20(end of follow-up)

    The adverse events reported in treatment

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2017
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.