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

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ClinicalTrials.gov Identifier: NCT03186079
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Shucheng Zhang, Shengjing Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Constipation Chinese Herbal Medicine Drug: Xiaojidaozhi Decoction oral capsules Drug: Placebo oral capsules Drug: Fiberform Behavioral: Toilet training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy of Chinese Herbal Medicine Xiaojidaozhi Decoction in the Treatment of Childhood Functional Constipation: a Double Blind, Randomized and Placebo-controlled Trial
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Xiaojidaozhi Decoction
Xiaojidaozhi Decoction and Fiberform and Toilet training are used for treatment of childhood Constipation
Drug: Xiaojidaozhi Decoction oral capsules
Capsules with mixture of twelve Chinese herbal medicines granule inside
Other Name: XJD

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

Placebo Comparator: non-Xiaojidaozhi Decoction
Placebo and Fiberform and Toilet training are used for treatment of childhood Constipation
Drug: Placebo oral capsules
Capsules with flour granule inside
Other Name: Placebos

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Within week 20(end of follow-up) ]
    The adverse events reported in treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Digestive tract diseases
  2. Neurologic diseases
  3. Endocrine diseases
  4. Metabolic diseases
  5. Gastrointestinal surgery
  6. Using drugs which can take impact on bowl motility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186079


Contacts
Contact: Shucheng ZHANG, MD 86-24-96615-57911 zhangshucheng76@126.com

Locations
China, Liaoning
Shengjing Hospital Recruiting
Shenyang, Liaoning, China, 110004
Contact: Shucheng ZHANG    86-24-96615-57911    zhangshucheng76@126.com   
Sponsors and Collaborators
Shengjing Hospital