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

NCT ID: NCT03186079

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-05-01

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.

Detailed Description

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Conditions

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Constipation Chinese Herbal Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Xiaojidaozhi Decoction

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

Group Type ACTIVE_COMPARATOR

Xiaojidaozhi Decoction

Intervention Type DRUG

Mixture of twelve Chinese herbal medicines granule

Fiberform

Intervention Type DRUG

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

Toilet training

Intervention Type BEHAVIORAL

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

non-Xiaojidaozhi Decoction

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Fiberform

Intervention Type DRUG

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

Toilet training

Intervention Type BEHAVIORAL

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

Interventions

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Xiaojidaozhi Decoction

Mixture of twelve Chinese herbal medicines granule

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Fiberform

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

Intervention Type DRUG

Toilet training

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

Intervention Type BEHAVIORAL

Other Intervention Names

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XJD Placebos

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shucheng Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shengjing Hospital

Shenyang, Liaoning, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 15479678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16000928 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21045817 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33938874 (View on PubMed)

Other Identifiers

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A333-2

Identifier Type: -

Identifier Source: org_study_id