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

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

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.

Study Overview

• Status: Completed
• Conditions: Constipation; Chinese Herbal Medicine
• Intervention / Treatment: Drug: Fiberform; Behavioral: Toilet training; Drug: Xiaojidaozhi Decoction; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Shucheng ZHANG, MD; Phone Number: 86-24-96615-57911; Email: zhangshucheng76@126.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Xiaojidaozhi Decoction; Xiaojidaozhi Decoction and Fiberform and Toilet training are used for treatment of childhood Constipation	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; Drug: Xiaojidaozhi Decoction; Mixture of twelve Chinese herbal medicines granule; Other Names: XJD
Placebo Comparator: non-Xiaojidaozhi Decoction; Placebo and Fiberform and Toilet training are used for treatment of childhood Constipation	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; Drug: Placebo; Mixture of 10% Chinese herbal medicines granule and 90% artificial gum; Other Names: Placebos

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: June 4, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: A333-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No