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

NCT03186079 | Completed Early Phase 1 DMC

• 1 other identifier: A333-2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation; Chinese Herbal Medicine

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Within week 20(end of follow-up)

Study Arms (2)

Xiaojidaozhi Decoction

ACTIVE COMPARATOR

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

Drug: Xiaojidaozhi Decoction; Drug: Fiberform; Behavioral: Toilet training

non-Xiaojidaozhi Decoction

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Fiberform; Behavioral: Toilet training

Interventions

Xiaojidaozhi Decoction DRUG

Mixture of twelve Chinese herbal medicines granule

Also known as: XJD

Xiaojidaozhi Decoction

Placebo DRUG

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

Also known as: Placebos

non-Xiaojidaozhi Decoction

Fiberform DRUG

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

Xiaojidaozhi Decoction; non-Xiaojidaozhi Decoction

Toilet training BEHAVIORAL

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

Xiaojidaozhi Decoction; non-Xiaojidaozhi Decoction

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

Related Publications (4)

• 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.

  PMID: 15479678 BACKGROUND

• 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.

  PMID: 16000928 BACKGROUND

• 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.

  PMID: 21045817 BACKGROUND

• 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.

  PMID: 33938874 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 4, 2017
• First Posted: June 14, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)