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

Study Overview
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Brief Summary
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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.

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

Conditions
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Constipation, Chinese Herbal Medicine

Intervention / Treatment
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* Drug: Xiaojidaozhi Decoction
* Drug: Placebo
* Drug: Fiberform
* Behavioral: Toilet training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Xiaojidaozhi Decoction<br>Xiaojidaozhi Decoction and Fiberform and Toilet training are used for treatment of childhood Constipation | Drug: Xiaojidaozhi Decoction<br>* Mixture of twelve Chinese herbal medicines granule<br>* Other names: XJD;Drug: Fiberform<br>* Fiberform is a low-phytate wheat fibre which can increase the gastrointestinal motility.<br>Behavioral: Toilet training<br>* Toilet training has been considered a routine method in treatment of constipation<br>|
| Placebo Comparator: non-Xiaojidaozhi Decoction<br>Placebo and Fiberform and Toilet training are used for treatment of childhood Constipation | Drug: Placebo<br>* Mixture of 10% Chinese herbal medicines granule and 90% artificial gum<br>* Other names: Placebos;Drug: Fiberform<br>* Fiberform is a low-phytate wheat fibre which can increase the gastrointestinal motility.<br>Behavioral: Toilet training<br>* Toilet training has been considered a routine method in treatment of constipation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of overall efficacy | Efficacy is ranked as cured, improved, same/worse | week 8(end of treatment) | 
| Percentage of overall efficacy | Efficacy is ranked as cured, improved, same/worse | week 20(end of follow-up) | 
| Baseline of constipation score in the beginning of treatment | Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence | beginning of treatment(baseline) | 
| Change of constipation score from the baseline in the end of treatment | Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence | week 8(end of treatment) | 
| Change of constipation score from the baseline in the end of follow-up | Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence | week 20(end of follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | The adverse events reported in treatment | Within week 20(end of follow-up) |