Efficacy of Chinese Herbal Medicine Xiaojidaozhi Decoction in the Treatment of Childhood Constipation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Xiaojidaozhi Decoction Xiaojidaozhi Decoction and Fiberform and Toilet training are used for treatment of childhood Constipation |
Drug: Xiaojidaozhi Decoction oral capsules
Capsules with mixture of twelve Chinese herbal medicines granule inside
Other Names:
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
|
| Placebo Comparator: non-Xiaojidaozhi Decoction Placebo and Fiberform and Toilet training are used for treatment of childhood Constipation |
Drug: Placebo oral capsules
Capsules with flour granule inside
Other Names:
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
|
Outcome Measures
Primary Outcome Measures
- Percentage of overall efficacy [week 8(end of treatment)]
Efficacy is ranked as cured, improved, same/worse
- Percentage of overall efficacy [week 20(end of follow-up)]
Efficacy is ranked as cured, improved, same/worse
- Baseline of constipation score in the beginning of treatment [beginning of treatment(baseline)]
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 [week 8(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 [week 20(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 [Within week 20(end of follow-up)]
The adverse events reported in treatment
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shengjing Hospital | Shenyang | Liaoning | China | 110004 |
Sponsors and Collaborators
- Shengjing Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Mäkel 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.
- A333-2