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

Primary Purpose

Constipation, Chinese Herbal Medicine

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Xiaojidaozhi Decoction oral capsules
Placebo oral capsules
Fiberform
Toilet training
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shengjing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Xiaojidaozhi Decoction

non-Xiaojidaozhi Decoction

Arm Description

Xiaojidaozhi Decoction and Fiberform and Toilet training are used for treatment of childhood Constipation

Placebo and Fiberform and Toilet training are used for treatment of childhood Constipation

Outcomes

Primary Outcome Measures

Percentage of overall efficacy
Efficacy is ranked as cured, improved, same/worse
Percentage of overall efficacy
Efficacy is ranked as cured, improved, same/worse
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
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
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

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
The adverse events reported in treatment

Full Information

First Posted
June 4, 2017
Last Updated
July 12, 2017
Sponsor
Shengjing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03186079
Brief Title
Efficacy of Chinese Herbal Medicine Xiaojidaozhi Decoction in the Treatment of Childhood Constipation
Official Title
Efficacy of Chinese Herbal Medicine Xiaojidaozhi Decoction in the Treatment of Childhood Functional Constipation: a Double Blind, Randomized and Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Chinese Herbal Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xiaojidaozhi Decoction
Arm Type
Active Comparator
Arm Description
Xiaojidaozhi Decoction and Fiberform and Toilet training are used for treatment of childhood Constipation
Arm Title
non-Xiaojidaozhi Decoction
Arm Type
Placebo Comparator
Arm Description
Placebo and Fiberform and Toilet training are used for treatment of childhood Constipation
Intervention Type
Drug
Intervention Name(s)
Xiaojidaozhi Decoction oral capsules
Other Intervention Name(s)
XJD
Intervention Description
Capsules with mixture of twelve Chinese herbal medicines granule inside
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsules
Other Intervention Name(s)
Placebos
Intervention Description
Capsules with flour granule inside
Intervention Type
Drug
Intervention Name(s)
Fiberform
Intervention Description
Fiberform is a low-phytate wheat fibre which can increase the gastrointestinal motility.
Intervention Type
Behavioral
Intervention Name(s)
Toilet training
Intervention Description
Toilet training has been considered a routine method in treatment of constipation
Primary Outcome Measure Information:
Title
Percentage of overall efficacy
Description
Efficacy is ranked as cured, improved, same/worse
Time Frame
week 8(end of treatment)
Title
Percentage of overall efficacy
Description
Efficacy is ranked as cured, improved, same/worse
Time Frame
week 20(end of follow-up)
Title
Baseline of constipation score in the beginning of treatment
Description
Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence
Time Frame
beginning of treatment(baseline)
Title
Change of constipation score from the baseline in the end of treatment
Description
Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence
Time Frame
week 8(end of treatment)
Title
Change of constipation score from the baseline in the end of follow-up
Description
Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence
Time Frame
week 20(end of follow-up)
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
The adverse events reported in treatment
Time Frame
Within week 20(end of follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shucheng ZHANG, MD
Phone
86-24-96615-57911
Email
zhangshucheng76@126.com
Facility Information:
Facility Name
Shengjing Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shucheng ZHANG
Phone
86-24-96615-57911
Email
zhangshucheng76@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15479678
Citation
Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Makel W, Taminiau J, Benninga M. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Gut. 2004 Nov;53(11):1590-4. doi: 10.1136/gut.2004.043620.
Results Reference
background
PubMed Identifier
16000928
Citation
Tran LC, Di Palma JA. Lack of lasting effectiveness of PEG 3350 laxative treatment of constipation. J Clin Gastroenterol. 2005 Aug;39(7):600-2. doi: 10.1097/01.mcg.0000170769.67320.47.
Results Reference
background
PubMed Identifier
21045817
Citation
Cheng CW, Bian ZX, Zhu LX, Wu JC, Sung JJ. Efficacy of a Chinese herbal proprietary medicine (Hemp Seed Pill) for functional constipation. Am J Gastroenterol. 2011 Jan;106(1):120-9. doi: 10.1038/ajg.2010.305. Epub 2010 Nov 2.
Results Reference
background
PubMed Identifier
33938874
Citation
Qiao L, Wang LJ, Wang Y, Chen Y, Zhang HL, Zhang SC. A Randomized, Double-Blind, and Placebo-Controlled Trial of Chinese Herbal Medicine in the Treatment of Childhood Constipation. Clin Transl Gastroenterol. 2021 May 3;12(5):e00345. doi: 10.14309/ctg.0000000000000345.
Results Reference
derived

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

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