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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186079
• Other study ID #: A333-2
• Status: Completed
• Phase: Early Phase 1
• Start date: May 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: November 2023
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Chinese Herbal Medicine
• Constipation

Intervention

Drug:
• Xiaojidaozhi Decoction
Mixture of twelve Chinese herbal medicines granule
• Placebo
Mixture of 10% Chinese herbal medicines granule and 90% artificial gum
• 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

Locations

Country	Name	City	State
China	Shengjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of overall efficacy	Efficacy is ranked as cured, improved, same/worse	week 8(end of treatment)
Primary	Percentage of overall efficacy	Efficacy is ranked as cured, improved, same/worse	week 20(end of follow-up)
Primary	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)
Primary	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)
Primary	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	Incidence of Treatment-Emergent Adverse Events	The adverse events reported in treatment	Within week 20(end of follow-up)